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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Key concepts</span><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0010" class="elsevierStylePara elsevierViewall">The use of compression devices in the hemostasis process in arteriovenous fistulas is considered negative in current clinical guidelines&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0015" class="elsevierStylePara elsevierViewall">The preferred method of hemostasis is manual compression&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0020" class="elsevierStylePara elsevierViewall">This recommendation is based on expert opinion&#44; but there is no published data to support it&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0025" class="elsevierStylePara elsevierViewall">Our data show that the pressure applied manually by the patient is not constant over time&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">&#8226;</span><p id="par0030" class="elsevierStylePara elsevierViewall">Furthermore&#44; it is shown that the use of a compression device that allows to be adjusted by the nurse exerts a pressure similar or lower than that applied manually by the patient&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Our results suggest that some of the premises that support the recommendation of the current clinical guidelines may not be precise&#46;</p></li></ul></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0040" class="elsevierStylePara elsevierViewall">Removal of the needles after a hemodialysis session in patients with arteriovenous fistulas &#40;AVF&#41; is as important as the cannulation process&#46; An adequate technique protects the wall of fistula from possible injuries and favors adequate hemostasis&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The application of correct pression on the puncture points favors their closure and reduces the risk of complications&#44; such as hematomas&#44; stenosis or thrombosis&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#8211;6</span></a> These adverse effects makes subsequent punctures difficult&#44; limits the number of options<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4</span></a> and&#44; finally&#44; the management of these patients becomes difficult&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">For the process of hemostasis&#44; the main clinical guidelines recommend applying compression with the fingertips for at least 10&#8239;min after removal of the needles&#44; the pressure has to be applied constantly and maintained until complete hemostasia is achieved&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#8211;9</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The use of compression devices &#40;clamps&#44; bands&#41; is also accepted in some of these guidelines&#44;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;7</span></a> while others prohibit or discourage their use&#44;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#44;8</span></a> arguing that these devices could apply excessive pressure and generate damage of the fistula&#46; This recommendation is based on expert consensus&#44; but to our knowledge&#44; there are no studies that provide data on which method of hemostasis is more appropriate&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Despite the negative consideration of the use of compression devices in AVF &#40;especially in prosthetics&#41;&#44; these are used in clinical practice&#46; There is a large number of this type devices available on the market&#46; Many of them have a regulation system that allows adjusting the compression exerted that could make them suitable for use in AVFs&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">It would be useful to have data on the feasibility and safety of the use of this type of device in clinical practice&#44; as well as its comparison with manual compression&#46; The objectives of the present study are&#58; &#40;a&#41; to assess the compression exerted with an adjustable clamp and compare it with that exerted manually&#44; and &#40;b&#41; to assess the intensity and variations of the pressure that is exerted manually on the AVF during the hemostasis process&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0070" class="elsevierStylePara elsevierViewall">Descriptive cross-sectional study comparing two compression methods in patients undergoing hemodialysis through native or prosthetic AVFs in the Hemodialysis Service of the Segovia Health Care Complex&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Sample&#44; sampling and sample size</span><p id="par0075" class="elsevierStylePara elsevierViewall">The patients included in the study are those undergoing hemodialysis through AVF in our hemodialysis Unit&#46; Patients excluded were those with complications in the AVF &#40;subcutaneous hematoma&#44; infection&#44; thrombosis&#41;&#44; a situation that implies an increased risk of vascular rupture &#40;according to the practitioner criteria&#41;&#44; or those with immature AVF&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The sample unit of the study is the hemodialysis session&#44; in which the intra-access pressure will be determined on several occasions according to the protocol described below&#46; Up to 10 hemodialysis sessions of the same patient are used in the study&#44; which are selected by simple random sampling from all the sessions received by each patient during the duration of the study&#46; Data from sessions in which the presence of fibrin in the system may skew the intra-access pressure reading&#44; as well as those in which a movement or change in position of the patient may alter the readings&#44; will be excluded&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">A minimum sample size of 37 hemodialysis sessions has been estimated necessary to evaluate the difference in pressure obtained by doing manual compression and that exerted by a compression device&#46; This was estimated considering a standard deviation of 15&#8239;mmHg&#44; a minimum difference to be detected of &#177;7&#8239;mmHg&#44; an alpha error of 0&#46;05&#44; and a statistical power of 20&#37;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Measurement of intra-access pressure</span><p id="par0090" class="elsevierStylePara elsevierViewall">Our Unit has 10 hemodialysis positions&#44; and in the present study we used 4 Gambro monitors&#58; Artis and Artis Physio&#44; and a Premifistola BL170 compression forceps &#40;Bellco&#44; Mirandola&#44; Italy&#41;&#44; to which an adjustable flange is attached to allow adjustment of the compression exerted on the AVF&#46; All nurses that participated in the study were experts in AVF cannulation&#44; with more than 3 years of experience in this technique&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The intra-access pressure measured by the monitor in the venous chamber of the system will be used as an indirect indicator of the pressure exerted on the puncture site&#46; It is read 6 times&#58; before removing the venous needle &#40;Basal&#41;&#44; after removing the venous needle and placing the clamp &#40;P1&#41;&#44; at the time of adjusting the clamp &#40;P2&#41;&#44; at the beginning of applying manual compression &#40;M0&#41; at 3&#8239;min after starting to exert manual pressure &#40;M3&#41; and at 6&#8239;min of manual pressure &#40;M6&#41;&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">At the end of the hemodialysis session&#44; the blood will be returned from the extracorporeal circuit according to the Unit&#8217;s protocol&#46; To obtain the pressure reading in the venous chamber&#44; the venous line will be connected to the arterial needle&#46; To equql the intra-access pressure&#44; the height of the patient&#8217;s bed and headboard will be adjusted to match the same level of the venous chamber&#46; In this way&#44; the differences associated with the increase in hydrostatic pressure will be eliminated&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;11</span></a></p><p id="par0105" class="elsevierStylePara elsevierViewall">Thereafter&#44; the line that communicates the venous chamber with the dialyzer will be clamped&#44; to prevent pressure changes from dissipating through this line&#46; After 30&#8239;s the pressure reading will be recorded&#44; which will be considered the basal pressure &#40;Basal&#41;&#46; Then the nurse will remove the venous needle&#44; place the compression device&#44; and adjust it to achieve hemostasis without interrupting flow through the fistula&#46; The presence of the <span class="elsevierStyleItalic">thrill</span> at points immediately before and after will indicate that the flow is sufficient&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> The nurse who places and adjusts the clamp will not have access to the intra-access pressure reading&#44; a second observer will measure the intra-access pressure when placing the clamp &#40;P1&#41; and when adjusting it &#40;P2&#41;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">After that&#44; the clamp will be removed and the patient will compress the hole to exert hemostasis&#46; At that time&#44; the pressure reading &#40;M0&#41; will be taken&#44; repeating the reading after 3&#8239;min &#40;M3&#41; and at min &#40;M6&#41;&#46; Again&#44; the person applying pressure will not have access to the pressure reading provided on the screen&#44; which will be recorded by a second observer&#46; After the 6&#8239;min reading &#40;M6&#41; will continue with the normal disconnection process of the patient&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">Manual compression will be as sustained and constant as possible&#44; sufficient to interrupt bleeding externally and subcutaneously&#44; but without interrupting the flow through the fistula&#46; The pressure will be exerted for at least 10&#8239;min&#44; until complete hemostasis is achieved&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> In our unit&#44; patients are instructed on how to compress after removing the needles&#46; In the event that the patient does not have sufficient cognitive&#47;functional capacity&#44; this pressure is exerted by the nurse&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Variables</span><p id="par0120" class="elsevierStylePara elsevierViewall">The differences in the values of pressures recorded &#8203;&#8203;&#40;Basal&#44; P1&#44; P2&#44; M0&#44; M3 and M6&#41; will be calculated&#46; In addition&#44; sociodemographic and clinical variables will be recorded&#44; such as the sex and age of the patient&#44; the type of AVF &#40;native or prosthetic&#41;&#44; location and age of the fistula&#44; treatment with antiplatelet aggregation&#44; anticoagulant or erythropoiesis stimulator treatment&#44; and parameters such as urea&#44; hemoglobin and the value of Kt&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Complications arising in the area of the fistula during the 48&#8239;h after the hemodialysis sessions attributable to the process of hemostasis will be also recorded&#44; such as external bleeding&#44; subcutaneous hematoma&#44; marked decrease in the flow of access&#44; infection&#44; stenosis or new onset pseudoaneurysm&#44; thrombosis&#44; vascular rupture&#44; etc&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0130" class="elsevierStylePara elsevierViewall">SPSS software v&#46;20&#46;0&#46;0 &#40;IBM Corporation&#44; &#169;2011&#44; USA&#41; will be used for data analysis&#46; In the descriptive analysis of the results&#44; means and standard deviations will be used for the quantitative variables and percentages for the qualitative ones&#46; All significance tests will be bilateral and a p value &#60;0&#46;05 is considered as statistically significant&#46; For estimates a confidence interval of 95&#37; &#40;CI be provided 95&#37;&#41;&#46; The Saphiro&#8211;Wilk test will be used to determine if the distribution of the data corresponding to each variable conforms to the normal distribution&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Comparison of intra-access pressure differences &#40;P2-M0&#44; P2-Basal&#44; M0-Basal&#44; etc&#46;&#41;&#44; are analyzed by using Student&#8217;s t test for paired samples there is a normal distribution&#46; Otherwise&#44; will use the Wilcoxon test for comparisons of related samples&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><p id="par0140" class="elsevierStylePara elsevierViewall">Data was collected from a total of 51 hemodialysis sessions in15 patients &#40;mean age&#44; 71&#46;33&#8239;&#177;&#8239;12&#46;66 years&#44; 9 females&#41;&#46; The mean value of urea prior to the hemodialysis session was 113&#46;41&#8239;mg&#47;dl &#40;range 88&#8722;180&#8239;mg&#47;dl&#41;&#46; The average Kt was 48&#46;42&#8239;&#177;&#8239;5&#46;70&#8239;l &#40;range 36&#8722;60&#8239;l&#41;&#46; A value of Kt below the optimum was observed in 2 &#40;3&#46;9&#37;&#41; sessions&#46; The mean value of hemoglobin before hemodialysis was 10&#46;81&#8239;&#177;&#8239;1&#46;21&#8239;g&#47;dl &#40;range 9&#46;60&#8211;13&#46;20&#8239;g&#47;dl&#41;&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">There were 4 patients that did not complete the study&#58; one was discontinued for presenting critical stenosis in the venous anastomosis and 3 patients died &#40;one sudden death and 2 due to advanced neoplasia&#41;&#46; The reasons for withdrawal of these 4 patients were not associated with the hemostasis process in the AVF&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Out of the 15 patients included&#44; 2 &#40;13&#46;3&#37;&#41; had a Gore-Tex prosthetic fistula implanted&#44; both of humerus-axillary location&#44; and results were obtained from 9 &#40;17&#46;6&#37;&#41; of the 51 sessions evaluated&#46; The remaining 13 &#40;86&#46;6&#37;&#41; patients had a native fistula&#44; in which data from 42 &#40;82&#46;3&#37;&#41; sessions were collected&#46; Of these 13 fistulas&#44; 8 were humerus-cephalic&#44; 3 radio-cephalic&#44; and 2 humerus-basilic&#46; The median age &#40;range&#41; of the fistulas was 592 &#40;3&#44;589&#41; days&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">Regarding the usual daily treatment&#44; 6 patients were on of acetylsalicylic acid 100&#8239;mg&#44; 2 on 100&#8239;mg of acetylsalicylic acid and 75&#8239;mg of clopidogrel&#44; and 2 were anticoagulated with 20&#8239;mg of enoxaparin&#46; All patients were anticoagulated with sodium enoxaparin at the beginning of the hemodialysis session&#44; with doses between 20 and 80&#8239;mg&#46; All patients received erythropoietin as a treatment for anemia&#46; During the development of the study&#44; none required transfusion of packed red blood cells&#46; In all the sessions analyzed&#44; an absorbable gelatin dressing &#40;Surgispon&#174;&#41; was used as coadjuvant hemostatic agent to apply pressure to the puncture site&#44; both with the forceps and with the patient&#8217;s fingers&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Of the 79 hemodialysis sessions initially included in the study&#44; 2 &#40;2&#46;5&#37;&#41; were excluded due to the fibrin deposition in the system that prevented the correct reading of intra-access pressure and 26 &#40;32&#46;9&#37;&#41; due to movements or changes in the position of the patient that affected the reliability of the readings&#46; Therefore&#44; in the final analysis&#44; the data from 51 sessions were considered&#46; In none of them there were complications that could be associated with the hemostasia process&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">The mean values &#8203;&#8203;and standard deviations of the intra-access pressure in each of the readings are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#44; and the mean values &#8203;&#8203;of the differences between each of the readings are presented in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#44; The distribution of these values &#8203;&#8203;are shown in <a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1 and 2</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0170" class="elsevierStylePara elsevierViewall">When placing the clamp to perform hemostasis&#44; and before being adjusted by the nurse &#40;P1&#41;&#44; the increase in pressure was &#43;31&#46;31&#8239;mmHg &#40;&#43;116&#46;56 &#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; with respect to the basal pressure&#46; Subsequently&#44; after being adjusted by the nurse &#40;P2&#41;&#44; the pressure decreased &#8722;16&#46;82&#8239;mmHg &#40;&#8722;28&#46;91&#37; compared to P1&#44; p&#8239;&#60;&#8239;0&#46;001&#41;&#46; At that time &#40;P2&#41; represented an increase of &#43;14&#46;49&#8239;mmHg &#40;&#43;53&#46;94&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; with respect to the basal pressure&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">The increase in pressure when puncture point was first pressed manually &#40;M0&#41; was &#43;23&#46;92&#8239;mmHg &#40;p&#8239;&#60;&#8239;0&#46;001&#41;&#44; representing an increase of &#43;89&#46;05&#37; as compared to baseline intra-access pressure&#46; From that moment&#44; the pressure exerted showed a downward trend&#44; with an average decrease of &#8722;8&#46;82&#8239;mmHg &#40;&#8722;17&#46;36&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; at 3&#8239;min &#40;M3&#41; and &#8722;12&#44; 55&#8239;mmHg &#40;&#8722;24&#46;71&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; at 6&#8239;min &#40;M6&#41;&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">After the clamp was adjusted by the nurse the pressure &#40;P2&#41; was lower than the values registered with the patient&#39;s manual pressure at minute zero &#40;M0&#41;&#59; the mean difference was -9&#46;43&#8239;mmHg &#40;&#8722;18&#46;57&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41;&#46; However&#44; it was observed that these values tended to be equal with M3 &#40;&#8722;0&#46;61&#8239;mmHg&#44; &#8722;1&#46;45&#37;&#44; p&#8239;&#61;&#8239;0&#46;901&#41; and M6 &#40;&#43;3&#44;12&#8239;mmHg&#44; &#43;8&#46;1&#37;&#44; p&#8239;&#61;&#8239;0&#46;102&#41;&#44; with a very similar distribution of values&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">None of the patients included in the study showed complications associated with the process of hemostasis within 48&#8239;h after the puncture of the fistula&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Discussion</span><p id="par0190" class="elsevierStylePara elsevierViewall">The results of this study show that the pressure exerted on the AVF by an adjustable compression system is equal to or less than that exerted manually by the patient&#46; In addition&#44; it has been shown that the manual pressure applied by the patient is not uniform over time and shows a descending pattern as the hemostasis process progresses&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Although these results may seem somewhat predictable&#44; they needed to be evaluated since there is not objective data in the literature and&#44; there is not information about which method of hemostasis would be more convenient&#46; In fact&#44; due to this lack of data&#44; the recommendations by clinical guidelines are currently based only on the consensus of experts&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">The recommendations assume that manual compression is the most appropriate and safe&#44; since it is moderate and constant over time&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;12</span></a> However&#44; our data reveal that manual pressure is not constant but decreases over time&#44; possibly due to a reduction of tone or to circumstances that decrease the concentration of the patient&#46; One of the advantages of compression devices would be that they would not be affected by these factors&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">The use of compression devices in AVF has a negative consideration in the guidelines&#44; so it is generally discouraged&#44; or allowed with restrictions in some situations&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2&#44;8&#44;13</span></a> This is based on the premise that they may exert excessive pressure on the fistula&#44; favor the development of complications and shorten its survival&#46; In any case&#44; as our data suggests&#44; this appears not to be the case with all devices&#46; The risk of a device applying inadequate compression to achieve hemostasis &#40;by excess or by defect&#41; is only expected in those devices that do not allow pressure adjustment&#44; or in adjustable devices that are not adequately supervised&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">As our results show&#44; the pressure exerted by a device that allows adjustment is similar to or less than that exerted manually by the patient&#46; This reveals several issues&#58; &#40;1&#41; that the premise of excessive pressure&#44; assumed in clinical guidelines&#44; would not be true in all devices&#44; only in those that do not have a system that allows adjustment&#59; &#40;2&#41; the importance of being used by trained personnel&#44; capable of determining the appropriate compression in each patient and in each session&#44; and &#40;3&#41; the need of a system that allows adjustment compression in all devices marketed for this purpose&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">However&#44; despite the usefulness of the data provided in this study&#44; they do not allow us to know the effect of the regular use of these devices in aspects as relevant as the occurrence of complications and survival of the fistula&#46; These are issues that must be addressed in future clinical trials&#44; the results of which would provide the first evidence on which to base the recommendations of the clinical guidelines&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">Although our results do not allow us to provide data regarding the safety of the continued use of these devices&#44; we did observe an absence of complications in the hemostasis process&#46; This has been the case even in patients with a more unfavorable uremic situation that has been associated with a greater risk of bleeding&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0225" class="elsevierStylePara elsevierViewall">Finally&#44; it should be mentioned that&#44; although the compression method is an important factor in determining the success of the hemostasis process&#44; it also depends on a correct cannulation technique which includes&#44; the use of the most appropriate type of needle for each patient &#40;length&#44; gauge&#44; fenestration&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> the use of the most appropriate technique<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> or the performance of an ultrasound-guided puncture when necessary&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> This can reduce the risk of a troublesome hemostasis process and the appearance of complications&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">Our study has some limitations&#46; Although we have used a sample size sufficient to determine the existence of pressure differences between the two methods&#44; this study has not evaluated the safety of the regular use of adjustable devices and its effects on the lifespan of the fistulas&#44; an issue that has been commented already&#46; Furthermore&#44; the small number of prosthetic fistulas included in the study did not allow us to analyze whether the results obtained would be applicable to this type of fistula&#46; In addition&#44; we have evaluated only one of the many compression devices on the market&#46; Although we think that our conclusions could be extended to any adjustable device&#44; there could be differences depending on the type of regulation system used &#40;continuous band&#44;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> discontinuous band&#44;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> bandage<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> or clamp<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> &#41;&#46; We have evaluated a clamp system&#44; that could have disadvantages as compared to other systems&#44; such as the possibility of displacement during the hemostasis process&#46; In this regard&#44; it would be interesting to be able to analyze the use of compression band systems&#44; which could be more effective in avoiding this problem&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">To conclude&#44; the results of this study have shown that the intensity of manual compression on the AVF decreases throughout the hemostasis process&#44; and that the compression exerted by a forceps after being adjusted by the nurse is lower or similar to that applied manually&#46; These data suggest that the premises on which some of the recommendations in the clinical guidelines are based could be imprecise&#44; such as that the compression exerted manually is constant over time&#44; or that all the devices exert excessive compression on the fistula&#46; However&#44; the role of routine use of adjustable compression devices in patient safety and fistula survival are issues that still need to be evaluated in future clinical trials&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conflict of interests</span><p id="par0240" class="elsevierStylePara elsevierViewall">None&#46;</p></span></span>"
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              "titulo" => "Variables"
            ]
            3 => array:2 [
              "identificador" => "sec0030"
              "titulo" => "Statistical analysis"
            ]
          ]
        ]
        6 => array:2 [
          "identificador" => "sec0035"
          "titulo" => "Results"
        ]
        7 => array:2 [
          "identificador" => "sec0040"
          "titulo" => "Discussion"
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        8 => array:2 [
          "identificador" => "sec0045"
          "titulo" => "Conflict of interests"
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        9 => array:1 [
          "titulo" => "References"
        ]
      ]
    ]
    "pdfFichero" => "main.pdf"
    "tienePdf" => true
    "fechaRecibido" => "2020-03-04"
    "fechaAceptado" => "2020-12-03"
    "PalabrasClave" => array:2 [
      "en" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Keywords"
          "identificador" => "xpalclavsec1457977"
          "palabras" => array:4 [
            0 => "Dialysis"
            1 => "Arteriovenous fistula"
            2 => "Hemostasis"
            3 => "Bleeding time"
          ]
        ]
      ]
      "es" => array:1 [
        0 => array:4 [
          "clase" => "keyword"
          "titulo" => "Palabras clave"
          "identificador" => "xpalclavsec1457976"
          "palabras" => array:4 [
            0 => "Di&#225;lisis"
            1 => "F&#237;stula arteriovenosa"
            2 => "Hemostasia"
            3 => "Tiempo de sangr&#237;a"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:2 [
      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objectives</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">To evaluate the pressure generated by an adjustable hemostasis clamp on arteriovenous fistulas &#40;AVF&#41; during the hemostasis proccess&#44; and compare it with the direct two-finger pressure applied by the patient&#46; To evaluate the variations of the direct two-finger pressure along the hemostasis process&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">We analyzed data obtained in 51 hemodialysis procedures from 15 patients&#46; AVF intraaccess pressure was used as indirect indicator of the pressure generated by both methods&#46; It was recorded before venous needle removal &#40;PBasal&#41;&#44; at clamp application &#40;P1&#41;&#44; after clamp adjustement by a nurse &#40;P2&#41;&#44; at the beginning of the direct two-finger pressure by the patient &#40;M0&#41;&#44; after 3&#8239;min of two-finger pressure &#40;M3&#41; and after 6&#8239;min of two-finger pressure &#40;M6&#41;&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Intra-access pressure was lower with the adjusted clamp &#40;P2&#41; than with the direct two-finger pressure by the patient &#40;M0&#41; &#40;variation of &#8722;18&#46;57&#37;&#44; 95&#37;CI &#8722;14&#46;09 to -4&#46;77&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#41;&#46; Intraaccess pressure generated by the direct two-finger pressure method showed a decreasing trend along the hemostasis process &#40;M3-M0&#58; &#8722;8&#46;82&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#59; M6-M0&#58; &#8722;12&#46;55&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">An adjustable fistula arm clamp generates a lower pressure in AVF than the direct two-finger pressure applied by the patient&#46; The latter showed a decreasing trend along the hemostasis process&#46; These data suggest that some of the recommendations from clinical guidelines could be based on inaccurate premises&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Background and objectives"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusion"
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      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Antecedentes y objetivo</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Valorar la presi&#243;n generada por una pinza ajustable en f&#237;stulas arteriovenosas &#40;FAV&#41; durante el proceso de hemostasia&#44; y compararla con la generada por la compresi&#243;n manual&#46; Evaluar las variaciones de la compresi&#243;n manual durante el proceso de hemostasia&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">Se analizaron los datos de 51 sesiones de hemodi&#225;lisis de 15 pacientes&#46; Se utiliz&#243; la presi&#243;n intraacceso como indicador indirecto de la presi&#243;n generada por ambos m&#233;todos sobre la FAV&#46; La misma se registr&#243; antes de retirar la aguja venosa &#40;PBasal&#41;&#44; tras retirar la aguja y colocar la pinza &#40;P1&#41;&#44; tras ajustar la pinza &#40;P2&#41;&#44; al comenzar el paciente a ejercer compresi&#243;n manual &#40;M0&#41;&#44; a los 3&#8239;min del inicio de la presi&#243;n manual &#40;M3&#41;&#44; y a los 6&#8239;min del inicio de la presi&#243;n manual &#40;M6&#41;&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">La presi&#243;n intraacceso fue menor al aplicar la pinza y ajustarla &#40;P2&#41; que al aplicar presi&#243;n manual &#40;M0&#41;&#44; con una diferencia media de &#8722;9&#44;43&#8239;mmHg &#40;variaci&#243;n &#8722;18&#44;57&#37;&#44; IC95&#37; &#8722;14&#44;09 a &#8722;4&#44;77&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#41;&#46; La presi&#243;n manual mostr&#243; una tendencia descendente durante el proceso de hemostasia &#40;M3-M0&#58; &#8722;8&#44;82&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#59; M6-M0&#58; &#8722;12&#44;55&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusi&#243;n</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La compresi&#243;n ejercida por una pinza ajustable es inferior o similar a la ejercida de forma manual por el paciente&#46; Esta &#250;ltima muestra una intensidad decreciente durante el proceso de hemostasia&#46; Estos datos sugieren que algunas de las premisas sobre las que se basan algunas de las recomendaciones presentes en las gu&#237;as cl&#237;nicas podr&#237;an ser imprecisas&#46;</p></span>"
        "secciones" => array:4 [
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            "identificador" => "abst0025"
            "titulo" => "Antecedentes y objetivo"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusi&#243;n"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; &#193;lvaro Crist&#243;bal A&#44; Par&#237;s Boal C&#44; Blanco Velasco N&#44; Matesanz Sanchidri&#225;n S&#44; Mayoral-Pe&#241;as A&#44; Ar&#233;valo Manso JJ&#44; et al&#46; Hemostasia en f&#237;stulas arteriovenosas&#58; comparaci&#243;n de la presi&#243;n manual con la ejercida por un dispositivo regulable&#46; Nefrologia&#46; 2021&#59;41&#58;566&#8211;572&#46;</p>"
      ]
    ]
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      0 => array:8 [
        "identificador" => "fig0005"
        "etiqueta" => "Fig&#46; 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr1.jpeg"
            "Alto" => 1206
            "Ancho" => 1583
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        ]
        "detalles" => array:1 [
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        "descripcion" => array:1 [
          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Distribution of values intra-access pressure &#8203;&#8203;&#40;mmHg&#41;&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without adjusting it&#59; P2&#58; after adjusting the compression using the adjustable system&#46;</p>"
        ]
      ]
      1 => array:8 [
        "identificador" => "fig0010"
        "etiqueta" => "Fig&#46; 2"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr2.jpeg"
            "Alto" => 1258
            "Ancho" => 1583
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0010"
            "detalle" => "Fig&#46; "
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        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Distribution of the values &#8203;&#8203;of differences of the intra-access pressure &#40;mmHg&#41;&#46;</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without being adjusted&#59; P2&#58; after adjusting the compression using the adjustable system&#46;</p> <p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The differences between basal and manual pressure are shown in white&#46; Medium gray shows the differences between basal pressure and adjustable clamp&#46; Differences between adjustable clamp and manual pressure are shown in dark gray&#46;</p>"
        ]
      ]
      2 => array:8 [
        "identificador" => "tbl0005"
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          "leyenda" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without being adjustited&#59; P2&#58; after adjusting the compression using the adjustable system&#59; SD&#58; standard deviation&#46;</p>"
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">26&#46;86&#8239;&#177;&#8239;15&#46;06&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">50&#46;78&#8239;&#177;&#8239;20&#46;54&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">9&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">97&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">38&#46;24&#8239;&#177;&#8239;17&#46;88&nbsp;\t\t\t\t\t\t\n
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          "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Mean&#44; minimum and maximum values &#8203;&#8203;of the intra-access pressure readings &#40;mmHg&#41;&#46;</p>"
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          "leyenda" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without adjustement&#59; P2&#58; after adjusting the compression using the adjustable system&#59; SD&#58; standard deviation&#59; Change &#37;&#58; percentage of variation&#59; 95&#37; CI&#58; 95&#37; confidence interval for the difference&#59; p&#58; statistical significance for the difference&#44; according to the Wilcoxon test for related samples&#46;</p>"
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Value&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Average&#8239;&#177;&#8239;SD&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Change &#37;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">95&#37; CI&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">p&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">M0-Basal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#43;89&#46;05&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">M3-M0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;11&#46;76 to &#8722;5&#46;89&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">M6-M0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;12&#46;55&#8239;&#177;&#8239;12&#46;91&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;24&#46;71&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">&#8722;16&#46;18 to &#8722;8&#46;92&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">&#60;0&#46;001&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">P1-Basal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#43;116&#46;56&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">26&#46;16 to 36&#46;47&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#60;0&#46;001&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">P2-Basal&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">14&#46;49&#8239;&#177;&#8239;13&#46;67&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#43;53&#46;94&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">10&#46;64 to 18&#46;33&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#60;0&#46;001&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">P2-P1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#8722;16&#46;82&#8239;&#177;&#8239;14&#46;55&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t">&#8722;28&#46;91&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">&#8722;20&#46;91 to &#8722;12&#46;73&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">P1-M0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  """
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          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Differences in the values of pressure &#40;mmHg&#41;&#46;</p>"
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                        0 => array:2 [
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                    0 => array:1 [
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                      "titulo" => "Spanish clinical guidelines on vascular access for haemodialysis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46; Ibeas"
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                            2 => "J&#46; Vallesp&#237;n"
                            3 => "T&#46; Moreno"
                            4 => "G&#46; Mo&#241;ux"
                            5 => "A&#46; Mart&#237;-Monr&#243;s"
                          ]
                        ]
                      ]
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                    0 => array:2 [
                      "doi" => "10.1016/j.nefro.2017.11.004"
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                        "tituloSerie" => "Nefrologia"
                        "fecha" => "2017"
                        "volumen" => "37 Suppl 1"
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                        "paginaFinal" => "191"
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                        0 => array:2 [
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                        ]
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                        "tituloSerie" => "J Vasc Access"
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                        "volumen" => "15"
                        "paginaInicial" => "102"
                        "paginaFinal" => "107"
                        "link" => array:1 [
                          0 => array:2 [
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Original article
Hemostasis of arteriovenous fistula: Comparison of direct two-finger pressure to an adjustable device
Hemostasia en fístulas arteriovenosas: comparación de la presión manual con la ejercida por un dispositivo regulable
Alejandro Álvaro Cristóbala,
Corresponding author
aalvaro@saludcastillayleon.es

Corresponding author.
, Carmen París Boala, Noelia Blanco Velascoa, Sergio Matesanz Sanchidriána, Azucena Mayoral-Peñasa, Juan José Arévalo Mansob,c, Sonia Velasco-Ballesterosa, María José Fernandez-Reyes Luisa
a Servicio de Nefrología, Unidad de Hemodiálisis, Complejo Asistencial de Segovia, Segovia, Spain
b Servicio de Asesoría en Investigación Sanitaria, Sección Sindical CSIF-Sanidad, Complejo Asistencial de Segovia, Segovia, Spain
c Unidad de Oncología, Hematología y Nefrología, Complejo Asistencial de Segovia, Segovia, Spain
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it is shown that the use of a compression device that allows to be adjusted by the nurse exerts a pressure similar or lower than that applied manually by the patient&#46;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">&#8226;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Our results suggest that some of the premises that support the recommendation of the current clinical guidelines may not be precise&#46;</p></li></ul></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0040" class="elsevierStylePara elsevierViewall">Removal of the needles after a hemodialysis session in patients with arteriovenous fistulas &#40;AVF&#41; is as important as the cannulation process&#46; An adequate technique protects the wall of fistula from possible injuries and favors adequate hemostasis&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The application of correct pression on the puncture points favors their closure and reduces the risk of complications&#44; such as hematomas&#44; stenosis or thrombosis&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#8211;6</span></a> These adverse effects makes subsequent punctures difficult&#44; limits the number of options<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4</span></a> and&#44; finally&#44; the management of these patients becomes difficult&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">For the process of hemostasis&#44; the main clinical guidelines recommend applying compression with the fingertips for at least 10&#8239;min after removal of the needles&#44; the pressure has to be applied constantly and maintained until complete hemostasia is achieved&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7&#8211;9</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The use of compression devices &#40;clamps&#44; bands&#41; is also accepted in some of these guidelines&#44;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;7</span></a> while others prohibit or discourage their use&#44;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;4&#44;8</span></a> arguing that these devices could apply excessive pressure and generate damage of the fistula&#46; This recommendation is based on expert consensus&#44; but to our knowledge&#44; there are no studies that provide data on which method of hemostasis is more appropriate&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Despite the negative consideration of the use of compression devices in AVF &#40;especially in prosthetics&#41;&#44; these are used in clinical practice&#46; There is a large number of this type devices available on the market&#46; Many of them have a regulation system that allows adjusting the compression exerted that could make them suitable for use in AVFs&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">It would be useful to have data on the feasibility and safety of the use of this type of device in clinical practice&#44; as well as its comparison with manual compression&#46; The objectives of the present study are&#58; &#40;a&#41; to assess the compression exerted with an adjustable clamp and compare it with that exerted manually&#44; and &#40;b&#41; to assess the intensity and variations of the pressure that is exerted manually on the AVF during the hemostasis process&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Methods</span><p id="par0070" class="elsevierStylePara elsevierViewall">Descriptive cross-sectional study comparing two compression methods in patients undergoing hemodialysis through native or prosthetic AVFs in the Hemodialysis Service of the Segovia Health Care Complex&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Sample&#44; sampling and sample size</span><p id="par0075" class="elsevierStylePara elsevierViewall">The patients included in the study are those undergoing hemodialysis through AVF in our hemodialysis Unit&#46; Patients excluded were those with complications in the AVF &#40;subcutaneous hematoma&#44; infection&#44; thrombosis&#41;&#44; a situation that implies an increased risk of vascular rupture &#40;according to the practitioner criteria&#41;&#44; or those with immature AVF&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">The sample unit of the study is the hemodialysis session&#44; in which the intra-access pressure will be determined on several occasions according to the protocol described below&#46; Up to 10 hemodialysis sessions of the same patient are used in the study&#44; which are selected by simple random sampling from all the sessions received by each patient during the duration of the study&#46; Data from sessions in which the presence of fibrin in the system may skew the intra-access pressure reading&#44; as well as those in which a movement or change in position of the patient may alter the readings&#44; will be excluded&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">A minimum sample size of 37 hemodialysis sessions has been estimated necessary to evaluate the difference in pressure obtained by doing manual compression and that exerted by a compression device&#46; This was estimated considering a standard deviation of 15&#8239;mmHg&#44; a minimum difference to be detected of &#177;7&#8239;mmHg&#44; an alpha error of 0&#46;05&#44; and a statistical power of 20&#37;&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Measurement of intra-access pressure</span><p id="par0090" class="elsevierStylePara elsevierViewall">Our Unit has 10 hemodialysis positions&#44; and in the present study we used 4 Gambro monitors&#58; Artis and Artis Physio&#44; and a Premifistola BL170 compression forceps &#40;Bellco&#44; Mirandola&#44; Italy&#41;&#44; to which an adjustable flange is attached to allow adjustment of the compression exerted on the AVF&#46; All nurses that participated in the study were experts in AVF cannulation&#44; with more than 3 years of experience in this technique&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">The intra-access pressure measured by the monitor in the venous chamber of the system will be used as an indirect indicator of the pressure exerted on the puncture site&#46; It is read 6 times&#58; before removing the venous needle &#40;Basal&#41;&#44; after removing the venous needle and placing the clamp &#40;P1&#41;&#44; at the time of adjusting the clamp &#40;P2&#41;&#44; at the beginning of applying manual compression &#40;M0&#41; at 3&#8239;min after starting to exert manual pressure &#40;M3&#41; and at 6&#8239;min of manual pressure &#40;M6&#41;&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">At the end of the hemodialysis session&#44; the blood will be returned from the extracorporeal circuit according to the Unit&#8217;s protocol&#46; To obtain the pressure reading in the venous chamber&#44; the venous line will be connected to the arterial needle&#46; To equql the intra-access pressure&#44; the height of the patient&#8217;s bed and headboard will be adjusted to match the same level of the venous chamber&#46; In this way&#44; the differences associated with the increase in hydrostatic pressure will be eliminated&#46;<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10&#44;11</span></a></p><p id="par0105" class="elsevierStylePara elsevierViewall">Thereafter&#44; the line that communicates the venous chamber with the dialyzer will be clamped&#44; to prevent pressure changes from dissipating through this line&#46; After 30&#8239;s the pressure reading will be recorded&#44; which will be considered the basal pressure &#40;Basal&#41;&#46; Then the nurse will remove the venous needle&#44; place the compression device&#44; and adjust it to achieve hemostasis without interrupting flow through the fistula&#46; The presence of the <span class="elsevierStyleItalic">thrill</span> at points immediately before and after will indicate that the flow is sufficient&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> The nurse who places and adjusts the clamp will not have access to the intra-access pressure reading&#44; a second observer will measure the intra-access pressure when placing the clamp &#40;P1&#41; and when adjusting it &#40;P2&#41;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">After that&#44; the clamp will be removed and the patient will compress the hole to exert hemostasis&#46; At that time&#44; the pressure reading &#40;M0&#41; will be taken&#44; repeating the reading after 3&#8239;min &#40;M3&#41; and at min &#40;M6&#41;&#46; Again&#44; the person applying pressure will not have access to the pressure reading provided on the screen&#44; which will be recorded by a second observer&#46; After the 6&#8239;min reading &#40;M6&#41; will continue with the normal disconnection process of the patient&#46;</p><p id="par0115" class="elsevierStylePara elsevierViewall">Manual compression will be as sustained and constant as possible&#44; sufficient to interrupt bleeding externally and subcutaneously&#44; but without interrupting the flow through the fistula&#46; The pressure will be exerted for at least 10&#8239;min&#44; until complete hemostasis is achieved&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> In our unit&#44; patients are instructed on how to compress after removing the needles&#46; In the event that the patient does not have sufficient cognitive&#47;functional capacity&#44; this pressure is exerted by the nurse&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Variables</span><p id="par0120" class="elsevierStylePara elsevierViewall">The differences in the values of pressures recorded &#8203;&#8203;&#40;Basal&#44; P1&#44; P2&#44; M0&#44; M3 and M6&#41; will be calculated&#46; In addition&#44; sociodemographic and clinical variables will be recorded&#44; such as the sex and age of the patient&#44; the type of AVF &#40;native or prosthetic&#41;&#44; location and age of the fistula&#44; treatment with antiplatelet aggregation&#44; anticoagulant or erythropoiesis stimulator treatment&#44; and parameters such as urea&#44; hemoglobin and the value of Kt&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Complications arising in the area of the fistula during the 48&#8239;h after the hemodialysis sessions attributable to the process of hemostasis will be also recorded&#44; such as external bleeding&#44; subcutaneous hematoma&#44; marked decrease in the flow of access&#44; infection&#44; stenosis or new onset pseudoaneurysm&#44; thrombosis&#44; vascular rupture&#44; etc&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Statistical analysis</span><p id="par0130" class="elsevierStylePara elsevierViewall">SPSS software v&#46;20&#46;0&#46;0 &#40;IBM Corporation&#44; &#169;2011&#44; USA&#41; will be used for data analysis&#46; In the descriptive analysis of the results&#44; means and standard deviations will be used for the quantitative variables and percentages for the qualitative ones&#46; All significance tests will be bilateral and a p value &#60;0&#46;05 is considered as statistically significant&#46; For estimates a confidence interval of 95&#37; &#40;CI be provided 95&#37;&#41;&#46; The Saphiro&#8211;Wilk test will be used to determine if the distribution of the data corresponding to each variable conforms to the normal distribution&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Comparison of intra-access pressure differences &#40;P2-M0&#44; P2-Basal&#44; M0-Basal&#44; etc&#46;&#41;&#44; are analyzed by using Student&#8217;s t test for paired samples there is a normal distribution&#46; Otherwise&#44; will use the Wilcoxon test for comparisons of related samples&#46;</p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Results</span><p id="par0140" class="elsevierStylePara elsevierViewall">Data was collected from a total of 51 hemodialysis sessions in15 patients &#40;mean age&#44; 71&#46;33&#8239;&#177;&#8239;12&#46;66 years&#44; 9 females&#41;&#46; The mean value of urea prior to the hemodialysis session was 113&#46;41&#8239;mg&#47;dl &#40;range 88&#8722;180&#8239;mg&#47;dl&#41;&#46; The average Kt was 48&#46;42&#8239;&#177;&#8239;5&#46;70&#8239;l &#40;range 36&#8722;60&#8239;l&#41;&#46; A value of Kt below the optimum was observed in 2 &#40;3&#46;9&#37;&#41; sessions&#46; The mean value of hemoglobin before hemodialysis was 10&#46;81&#8239;&#177;&#8239;1&#46;21&#8239;g&#47;dl &#40;range 9&#46;60&#8211;13&#46;20&#8239;g&#47;dl&#41;&#46;</p><p id="par0145" class="elsevierStylePara elsevierViewall">There were 4 patients that did not complete the study&#58; one was discontinued for presenting critical stenosis in the venous anastomosis and 3 patients died &#40;one sudden death and 2 due to advanced neoplasia&#41;&#46; The reasons for withdrawal of these 4 patients were not associated with the hemostasis process in the AVF&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Out of the 15 patients included&#44; 2 &#40;13&#46;3&#37;&#41; had a Gore-Tex prosthetic fistula implanted&#44; both of humerus-axillary location&#44; and results were obtained from 9 &#40;17&#46;6&#37;&#41; of the 51 sessions evaluated&#46; The remaining 13 &#40;86&#46;6&#37;&#41; patients had a native fistula&#44; in which data from 42 &#40;82&#46;3&#37;&#41; sessions were collected&#46; Of these 13 fistulas&#44; 8 were humerus-cephalic&#44; 3 radio-cephalic&#44; and 2 humerus-basilic&#46; The median age &#40;range&#41; of the fistulas was 592 &#40;3&#44;589&#41; days&#46;</p><p id="par0155" class="elsevierStylePara elsevierViewall">Regarding the usual daily treatment&#44; 6 patients were on of acetylsalicylic acid 100&#8239;mg&#44; 2 on 100&#8239;mg of acetylsalicylic acid and 75&#8239;mg of clopidogrel&#44; and 2 were anticoagulated with 20&#8239;mg of enoxaparin&#46; All patients were anticoagulated with sodium enoxaparin at the beginning of the hemodialysis session&#44; with doses between 20 and 80&#8239;mg&#46; All patients received erythropoietin as a treatment for anemia&#46; During the development of the study&#44; none required transfusion of packed red blood cells&#46; In all the sessions analyzed&#44; an absorbable gelatin dressing &#40;Surgispon&#174;&#41; was used as coadjuvant hemostatic agent to apply pressure to the puncture site&#44; both with the forceps and with the patient&#8217;s fingers&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Of the 79 hemodialysis sessions initially included in the study&#44; 2 &#40;2&#46;5&#37;&#41; were excluded due to the fibrin deposition in the system that prevented the correct reading of intra-access pressure and 26 &#40;32&#46;9&#37;&#41; due to movements or changes in the position of the patient that affected the reliability of the readings&#46; Therefore&#44; in the final analysis&#44; the data from 51 sessions were considered&#46; In none of them there were complications that could be associated with the hemostasia process&#46;</p><p id="par0165" class="elsevierStylePara elsevierViewall">The mean values &#8203;&#8203;and standard deviations of the intra-access pressure in each of the readings are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#44; and the mean values &#8203;&#8203;of the differences between each of the readings are presented in <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#44; The distribution of these values &#8203;&#8203;are shown in <a class="elsevierStyleCrossRefs" href="#fig0005">Figs&#46; 1 and 2</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0170" class="elsevierStylePara elsevierViewall">When placing the clamp to perform hemostasis&#44; and before being adjusted by the nurse &#40;P1&#41;&#44; the increase in pressure was &#43;31&#46;31&#8239;mmHg &#40;&#43;116&#46;56 &#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; with respect to the basal pressure&#46; Subsequently&#44; after being adjusted by the nurse &#40;P2&#41;&#44; the pressure decreased &#8722;16&#46;82&#8239;mmHg &#40;&#8722;28&#46;91&#37; compared to P1&#44; p&#8239;&#60;&#8239;0&#46;001&#41;&#46; At that time &#40;P2&#41; represented an increase of &#43;14&#46;49&#8239;mmHg &#40;&#43;53&#46;94&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; with respect to the basal pressure&#46;</p><p id="par0175" class="elsevierStylePara elsevierViewall">The increase in pressure when puncture point was first pressed manually &#40;M0&#41; was &#43;23&#46;92&#8239;mmHg &#40;p&#8239;&#60;&#8239;0&#46;001&#41;&#44; representing an increase of &#43;89&#46;05&#37; as compared to baseline intra-access pressure&#46; From that moment&#44; the pressure exerted showed a downward trend&#44; with an average decrease of &#8722;8&#46;82&#8239;mmHg &#40;&#8722;17&#46;36&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; at 3&#8239;min &#40;M3&#41; and &#8722;12&#44; 55&#8239;mmHg &#40;&#8722;24&#46;71&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41; at 6&#8239;min &#40;M6&#41;&#46;</p><p id="par0180" class="elsevierStylePara elsevierViewall">After the clamp was adjusted by the nurse the pressure &#40;P2&#41; was lower than the values registered with the patient&#39;s manual pressure at minute zero &#40;M0&#41;&#59; the mean difference was -9&#46;43&#8239;mmHg &#40;&#8722;18&#46;57&#37;&#44; p&#8239;&#60;&#8239;0&#46;001&#41;&#46; However&#44; it was observed that these values tended to be equal with M3 &#40;&#8722;0&#46;61&#8239;mmHg&#44; &#8722;1&#46;45&#37;&#44; p&#8239;&#61;&#8239;0&#46;901&#41; and M6 &#40;&#43;3&#44;12&#8239;mmHg&#44; &#43;8&#46;1&#37;&#44; p&#8239;&#61;&#8239;0&#46;102&#41;&#44; with a very similar distribution of values&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">None of the patients included in the study showed complications associated with the process of hemostasis within 48&#8239;h after the puncture of the fistula&#46;</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Discussion</span><p id="par0190" class="elsevierStylePara elsevierViewall">The results of this study show that the pressure exerted on the AVF by an adjustable compression system is equal to or less than that exerted manually by the patient&#46; In addition&#44; it has been shown that the manual pressure applied by the patient is not uniform over time and shows a descending pattern as the hemostasis process progresses&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Although these results may seem somewhat predictable&#44; they needed to be evaluated since there is not objective data in the literature and&#44; there is not information about which method of hemostasis would be more convenient&#46; In fact&#44; due to this lack of data&#44; the recommendations by clinical guidelines are currently based only on the consensus of experts&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">The recommendations assume that manual compression is the most appropriate and safe&#44; since it is moderate and constant over time&#46;<a class="elsevierStyleCrossRefs" href="#bib0010"><span class="elsevierStyleSup">2&#44;12</span></a> However&#44; our data reveal that manual pressure is not constant but decreases over time&#44; possibly due to a reduction of tone or to circumstances that decrease the concentration of the patient&#46; One of the advantages of compression devices would be that they would not be affected by these factors&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">The use of compression devices in AVF has a negative consideration in the guidelines&#44; so it is generally discouraged&#44; or allowed with restrictions in some situations&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;2&#44;8&#44;13</span></a> This is based on the premise that they may exert excessive pressure on the fistula&#44; favor the development of complications and shorten its survival&#46; In any case&#44; as our data suggests&#44; this appears not to be the case with all devices&#46; The risk of a device applying inadequate compression to achieve hemostasis &#40;by excess or by defect&#41; is only expected in those devices that do not allow pressure adjustment&#44; or in adjustable devices that are not adequately supervised&#46;</p><p id="par0210" class="elsevierStylePara elsevierViewall">As our results show&#44; the pressure exerted by a device that allows adjustment is similar to or less than that exerted manually by the patient&#46; This reveals several issues&#58; &#40;1&#41; that the premise of excessive pressure&#44; assumed in clinical guidelines&#44; would not be true in all devices&#44; only in those that do not have a system that allows adjustment&#59; &#40;2&#41; the importance of being used by trained personnel&#44; capable of determining the appropriate compression in each patient and in each session&#44; and &#40;3&#41; the need of a system that allows adjustment compression in all devices marketed for this purpose&#46;</p><p id="par0215" class="elsevierStylePara elsevierViewall">However&#44; despite the usefulness of the data provided in this study&#44; they do not allow us to know the effect of the regular use of these devices in aspects as relevant as the occurrence of complications and survival of the fistula&#46; These are issues that must be addressed in future clinical trials&#44; the results of which would provide the first evidence on which to base the recommendations of the clinical guidelines&#46;</p><p id="par0220" class="elsevierStylePara elsevierViewall">Although our results do not allow us to provide data regarding the safety of the continued use of these devices&#44; we did observe an absence of complications in the hemostasis process&#46; This has been the case even in patients with a more unfavorable uremic situation that has been associated with a greater risk of bleeding&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="par0225" class="elsevierStylePara elsevierViewall">Finally&#44; it should be mentioned that&#44; although the compression method is an important factor in determining the success of the hemostasis process&#44; it also depends on a correct cannulation technique which includes&#44; the use of the most appropriate type of needle for each patient &#40;length&#44; gauge&#44; fenestration&#41;&#44;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> the use of the most appropriate technique<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> or the performance of an ultrasound-guided puncture when necessary&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> This can reduce the risk of a troublesome hemostasis process and the appearance of complications&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">Our study has some limitations&#46; Although we have used a sample size sufficient to determine the existence of pressure differences between the two methods&#44; this study has not evaluated the safety of the regular use of adjustable devices and its effects on the lifespan of the fistulas&#44; an issue that has been commented already&#46; Furthermore&#44; the small number of prosthetic fistulas included in the study did not allow us to analyze whether the results obtained would be applicable to this type of fistula&#46; In addition&#44; we have evaluated only one of the many compression devices on the market&#46; Although we think that our conclusions could be extended to any adjustable device&#44; there could be differences depending on the type of regulation system used &#40;continuous band&#44;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> discontinuous band&#44;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> bandage<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> or clamp<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> &#41;&#46; We have evaluated a clamp system&#44; that could have disadvantages as compared to other systems&#44; such as the possibility of displacement during the hemostasis process&#46; In this regard&#44; it would be interesting to be able to analyze the use of compression band systems&#44; which could be more effective in avoiding this problem&#46;</p><p id="par0235" class="elsevierStylePara elsevierViewall">To conclude&#44; the results of this study have shown that the intensity of manual compression on the AVF decreases throughout the hemostasis process&#44; and that the compression exerted by a forceps after being adjusted by the nurse is lower or similar to that applied manually&#46; These data suggest that the premises on which some of the recommendations in the clinical guidelines are based could be imprecise&#44; such as that the compression exerted manually is constant over time&#44; or that all the devices exert excessive compression on the fistula&#46; However&#44; the role of routine use of adjustable compression devices in patient safety and fistula survival are issues that still need to be evaluated in future clinical trials&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Conflict of interests</span><p id="par0240" class="elsevierStylePara elsevierViewall">None&#46;</p></span></span>"
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      "en" => array:3 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Background and objectives</span><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">To evaluate the pressure generated by an adjustable hemostasis clamp on arteriovenous fistulas &#40;AVF&#41; during the hemostasis proccess&#44; and compare it with the direct two-finger pressure applied by the patient&#46; To evaluate the variations of the direct two-finger pressure along the hemostasis process&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">We analyzed data obtained in 51 hemodialysis procedures from 15 patients&#46; AVF intraaccess pressure was used as indirect indicator of the pressure generated by both methods&#46; It was recorded before venous needle removal &#40;PBasal&#41;&#44; at clamp application &#40;P1&#41;&#44; after clamp adjustement by a nurse &#40;P2&#41;&#44; at the beginning of the direct two-finger pressure by the patient &#40;M0&#41;&#44; after 3&#8239;min of two-finger pressure &#40;M3&#41; and after 6&#8239;min of two-finger pressure &#40;M6&#41;&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Intra-access pressure was lower with the adjusted clamp &#40;P2&#41; than with the direct two-finger pressure by the patient &#40;M0&#41; &#40;variation of &#8722;18&#46;57&#37;&#44; 95&#37;CI &#8722;14&#46;09 to -4&#46;77&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#41;&#46; Intraaccess pressure generated by the direct two-finger pressure method showed a decreasing trend along the hemostasis process &#40;M3-M0&#58; &#8722;8&#46;82&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#59; M6-M0&#58; &#8722;12&#46;55&#8239;mmHg&#44; <span class="elsevierStyleItalic">P</span>&#8239;&#60;&#8239;0&#46;001&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">An adjustable fistula arm clamp generates a lower pressure in AVF than the direct two-finger pressure applied by the patient&#46; The latter showed a decreasing trend along the hemostasis process&#46; These data suggest that some of the recommendations from clinical guidelines could be based on inaccurate premises&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0005"
            "titulo" => "Background and objectives"
          ]
          1 => array:2 [
            "identificador" => "abst0010"
            "titulo" => "Methods"
          ]
          2 => array:2 [
            "identificador" => "abst0015"
            "titulo" => "Results"
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          3 => array:2 [
            "identificador" => "abst0020"
            "titulo" => "Conclusion"
          ]
        ]
      ]
      "es" => array:3 [
        "titulo" => "Resumen"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Antecedentes y objetivo</span><p id="spar0070" class="elsevierStyleSimplePara elsevierViewall">Valorar la presi&#243;n generada por una pinza ajustable en f&#237;stulas arteriovenosas &#40;FAV&#41; durante el proceso de hemostasia&#44; y compararla con la generada por la compresi&#243;n manual&#46; Evaluar las variaciones de la compresi&#243;n manual durante el proceso de hemostasia&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">M&#233;todos</span><p id="spar0075" class="elsevierStyleSimplePara elsevierViewall">Se analizaron los datos de 51 sesiones de hemodi&#225;lisis de 15 pacientes&#46; Se utiliz&#243; la presi&#243;n intraacceso como indicador indirecto de la presi&#243;n generada por ambos m&#233;todos sobre la FAV&#46; La misma se registr&#243; antes de retirar la aguja venosa &#40;PBasal&#41;&#44; tras retirar la aguja y colocar la pinza &#40;P1&#41;&#44; tras ajustar la pinza &#40;P2&#41;&#44; al comenzar el paciente a ejercer compresi&#243;n manual &#40;M0&#41;&#44; a los 3&#8239;min del inicio de la presi&#243;n manual &#40;M3&#41;&#44; y a los 6&#8239;min del inicio de la presi&#243;n manual &#40;M6&#41;&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0080" class="elsevierStyleSimplePara elsevierViewall">La presi&#243;n intraacceso fue menor al aplicar la pinza y ajustarla &#40;P2&#41; que al aplicar presi&#243;n manual &#40;M0&#41;&#44; con una diferencia media de &#8722;9&#44;43&#8239;mmHg &#40;variaci&#243;n &#8722;18&#44;57&#37;&#44; IC95&#37; &#8722;14&#44;09 a &#8722;4&#44;77&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#41;&#46; La presi&#243;n manual mostr&#243; una tendencia descendente durante el proceso de hemostasia &#40;M3-M0&#58; &#8722;8&#44;82&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#59; M6-M0&#58; &#8722;12&#44;55&#8239;mmHg&#44; p&#8239;&#60;&#8239;0&#44;001&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusi&#243;n</span><p id="spar0085" class="elsevierStyleSimplePara elsevierViewall">La compresi&#243;n ejercida por una pinza ajustable es inferior o similar a la ejercida de forma manual por el paciente&#46; Esta &#250;ltima muestra una intensidad decreciente durante el proceso de hemostasia&#46; Estos datos sugieren que algunas de las premisas sobre las que se basan algunas de las recomendaciones presentes en las gu&#237;as cl&#237;nicas podr&#237;an ser imprecisas&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Antecedentes y objetivo"
          ]
          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "M&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
            "titulo" => "Conclusi&#243;n"
          ]
        ]
      ]
    ]
    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; &#193;lvaro Crist&#243;bal A&#44; Par&#237;s Boal C&#44; Blanco Velasco N&#44; Matesanz Sanchidri&#225;n S&#44; Mayoral-Pe&#241;as A&#44; Ar&#233;valo Manso JJ&#44; et al&#46; Hemostasia en f&#237;stulas arteriovenosas&#58; comparaci&#243;n de la presi&#243;n manual con la ejercida por un dispositivo regulable&#46; Nefrologia&#46; 2021&#59;41&#58;566&#8211;572&#46;</p>"
      ]
    ]
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      0 => array:8 [
        "identificador" => "fig0005"
        "etiqueta" => "Fig&#46; 1"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr1.jpeg"
            "Alto" => 1206
            "Ancho" => 1583
            "Tamanyo" => 55810
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0005"
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        "descripcion" => array:1 [
          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Distribution of values intra-access pressure &#8203;&#8203;&#40;mmHg&#41;&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without adjusting it&#59; P2&#58; after adjusting the compression using the adjustable system&#46;</p>"
        ]
      ]
      1 => array:8 [
        "identificador" => "fig0010"
        "etiqueta" => "Fig&#46; 2"
        "tipo" => "MULTIMEDIAFIGURA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "figura" => array:1 [
          0 => array:4 [
            "imagen" => "gr2.jpeg"
            "Alto" => 1258
            "Ancho" => 1583
            "Tamanyo" => 66447
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        "detalles" => array:1 [
          0 => array:3 [
            "identificador" => "at0010"
            "detalle" => "Fig&#46; "
            "rol" => "short"
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        ]
        "descripcion" => array:1 [
          "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Distribution of the values &#8203;&#8203;of differences of the intra-access pressure &#40;mmHg&#41;&#46;</p> <p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without being adjusted&#59; P2&#58; after adjusting the compression using the adjustable system&#46;</p> <p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The differences between basal and manual pressure are shown in white&#46; Medium gray shows the differences between basal pressure and adjustable clamp&#46; Differences between adjustable clamp and manual pressure are shown in dark gray&#46;</p>"
        ]
      ]
      2 => array:8 [
        "identificador" => "tbl0005"
        "etiqueta" => "Table 1"
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        "detalles" => array:1 [
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            "identificador" => "at0015"
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          "leyenda" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without being adjustited&#59; P2&#58; after adjusting the compression using the adjustable system&#59; SD&#58; standard deviation&#46;</p>"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Average SD&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Basal&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">55&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">26&#46;86&#8239;&#177;&#8239;15&#46;06&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t\ttop\n
                  \t\t\t\t">M0&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
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                  \t\t\t\t">14&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">102&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">50&#46;78&#8239;&#177;&#8239;20&#46;54&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">M3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">13&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">96&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">41&#46;96&#8239;&#177;&#8239;18&#46;09&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">M6&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">9&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">97&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">38&#46;24&#8239;&#177;&#8239;17&#46;88&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">P1&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">22&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">100&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">58&#46;18&#8239;&#177;&#8239;20&#46;29&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">P2&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">eleven&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">95&nbsp;\t\t\t\t\t\t\n
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        "descripcion" => array:1 [
          "en" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Mean&#44; minimum and maximum values &#8203;&#8203;of the intra-access pressure readings &#40;mmHg&#41;&#46;</p>"
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      ]
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          "leyenda" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Basal&#58; without exerting compression on the arteriovenous fistula&#59; M0&#58; at the start of manual compression&#59; M3&#58; minute 3 of manual compression&#59; M6&#58; minute 6 of manual compression&#59; Q1&#58; when placing the clamp&#44; without adjustement&#59; P2&#58; after adjusting the compression using the adjustable system&#59; SD&#58; standard deviation&#59; Change &#37;&#58; percentage of variation&#59; 95&#37; CI&#58; 95&#37; confidence interval for the difference&#59; p&#58; statistical significance for the difference&#44; according to the Wilcoxon test for related samples&#46;</p>"
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ISSN: 20132514
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Nefrología (English Edition)