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Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients

Study of Pain, Anxiety, Complications Related to AV Fistula Cannulation in Chronic Hemodialysis Patients. A. Buttonhole vs. Rope Ladder Technique B. Catheters With Cylindrical Point vs. Catheters With Bevel Point in Rope Ladder Technique

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00544492
Enrollment
40
Registered
2007-10-16
Start date
2007-10-31
Completion date
2010-03-31
Last updated
2011-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis, Fistula

Keywords

arteriovenous fistula, dialysis access, pain, anxiety, fistula related complications, aneurysm

Brief summary

A. Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. B. Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients. The above background information gives rise to the following investigational questions: A. Buttonhole vs rope ladder technique 1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique. 2. Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique. 3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique. 4. Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique. B. Rope ladder technique using catheters with cylindrical vs. bevel point 5. Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point? Hypothesis: AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.

Detailed description

A. Pain and other disadvantages of AV fistula cannulation can be limited by using the so-called buttonhole technique. It was described for the first time as the contant site method by Twardowski et al. The authors report on a patient in whom the fistula was too short to use the rope ladder technique. As an alternative, the access was cannulated at a constant site. Later, in 1984, Krönung used the name buttonhole puncture technique. It was used primarily in patients treated with home hemodialysis, where cannulation was performed by one single person (often by the patient himself). In order to form a perfect buttonhole it is indeed essential that the fistula is cannulated at exactly the same site and using exactly the same angle every single time. The buttonhole technique has been adopted by the recent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) Guidelines for vascular access. Studies show that patient pain scores and bleeding time after dialysis are positively influenced when using this cannulation technique. B. Till present in our center catheters with cylindrical points are used for cannulation of AV fistulas with the rope ladder technique. One can hypothesize that a catheter with a bevel point might have some advantages such as a larger entrance area and less traumatic cannulation. The latter may influence pain sensation of the patients. The above background information gives rise to the following investigational questions: A. Buttonhole vs rope ladder technique 1. Is pain sensation different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less pain than cannulation by rope ladder technique. 2. Is the level of anxiety different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: AV fistula cannulation by buttonhole technique causes less anxiety than cannulation by rope ladder technique. 3. Is bleeding time different when using buttonhole cannulation as compared to rope ladder cannulation technique? Hypothesis: Bleeding time is shorter when using buttonhole technique versus rope ladder technique. 4. Is the number and severity of complications related to AV fistula cannulation different between buttonhole and rope ladder technique? Hypothesis: When using the buttonhole technique for AV fistula cannulation the number and severity of complications is less than when using the rope ladder technique. B. Ropeladder technique using catheters with cylindrical vs. bevel point 5. Is pain sensation different when using rope ladder cannulation catheters with cylindrical as compared to bevel point? Hypothesis: AV fistula cannulation using bevel point catheters causes less pain than cannulation using cylindrical point catheters.

Interventions

DEVICEcatheter for AV fistula cannulation

catheters for buttonhole technique (blunt, bevel point), catheters for rope ladder technique (sharp, bevel point or sharp, cylindrical point)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* chronic hemodialysis * at least 18 years of age * AV fistula for vascular access * speaking the Dutch language

Exclusion criteria

* lack of informed consent

Design outcomes

Primary

MeasureTime frame
A. Buttonhole vs. rope ladder AV fistula cannulation, comparison of pain, anxiety, bleeding time and fistula related complications B. Rope ladder AV fistula cannulation using catheters with cylindrical vs. bevel point, comparison of pain6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026