Dialysis Clinical Trial
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
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Gasthuisberg | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. Review. — View Citation
Ball LK. The buttonhole technique for arteriovenous fistula cannulation. Nephrol Nurs J. 2006 May-Jun;33(3):299-304. Review. — View Citation
Lloyd G, McLauchlan A. Nurses' attitudes towards management of pain. Nurs Times. 1994 Oct 26-Nov 1;90(43):40-3. — View 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. — View Citation
McDonald DD, Sterling R. Acute pain reduction strategies used by well older adults. Int J Nurs Stud. 1998 Oct;35(5):265-70. — View 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. — View Citation
Sands JJ. Increasing AV fistulae and decreasing dialysis catheters: two aspects of improving patient outcomes. Blood Purif. 2007;25(1):99-102. Epub 2006 Dec 14. — View 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. Erratum in: J Am Gerriatr Soc 1998 Jul;46(7):913. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 6 months | Yes |
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