Clinical trial NCT00544492: Study of Pain, Anxiety and Complications Related to Cannulation of Arteriovenous (AV) Fistula in Chronic Hemodialysis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dialysis
Fistula
Keywords: arteriovenous fistula
dialysis access
pain
anxiety
fistula related complications
aneurysm
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
Study officials:
affiliation: University Hospital Gasthuisberg Leuven, Belgium
name: Bert RM Bammens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. doi: 10.1159/000096404. Epub 2006 Dec 14.
citation: Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
citation: Marticorena RM, Hunter J, Macleod S, Petershofer E, Dacouris N, Donnelly S, Goldstein MB. The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators. Hemodial Int. 2006 Apr;10(2):193-200. doi: 10.1111/j.1542-4758.2006.00094.x.
citation: Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304.
citation: Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3.
citation: McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. doi: 10.1016/s0020-7489(98)00039-x.
citation: Miller CD, Robbin ML, Allon M. Gender differences in outcomes of arteriovenous fistulas in hemodialysis patients. Kidney Int. 2003 Jan;63(1):346-52. doi: 10.1046/j.1523-1755.2003.00740.x.
citation: The management of chronic pain in older persons: AGS Panel on Chronic Pain in Older Persons. American Geriatrics Society. J Am Geriatr Soc. 1998 May;46(5):635-51. doi: 10.1111/j.1532-5415.1998.tb01084.x. No abstract available.