The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to two different methods of putting needles in their arteriovenous fistula and, 2) if we can adequately coordinate all of the sites to get useful multicentre trial data
To determine the feasibility of 1) randomizing patients to step-ladder versus buttonhole cannulation techniques, and 2) coordinating the multiple Canadian sites that are required for the definitive study. Secondary Objectives: To determine 1) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced training time for high dose home hemodialysis patients, 2) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced overall cost, 3) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced complications (infection - local and systemic, radiologic/surgical interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm formation, missed insertions), and 4) if buttonhole cannulation, compared to step-ladder cannulation is associated with reduced patient discomfort with needling for intensive home hemodialysis patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation
Foothills Hospital
Calgary, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Feasibility of Participant Recruitment and Site Coordination
The percent of qualified patients enrolled in the study for the pilot study to be successful will be ≥70%. If we can not reach this target we will not move forward with the definitive study. The pilot study will also allow us to see if we can coordinate multiple sites in needling techniques and determine if we can move forward with the definitive study.
Time frame: 2 years
Participant Training Time
Time in Days that it takes to train participants to perform home hemodialysis (document time in days from start of training until discharge home to do self-care). Unit of measure is number of days required to independently perform home hemodialysis
Time frame: Up to 90 days
Cost
Will incorporate the cost of training and complications
Time frame: 12 Months
Number of Participants With Complications
To determine whether buttonhole cannulation, compared to step-ladder cannulation, is associated with reduced complications (infection - local and systemic, radiologic/surgical interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm formation, missed insertions).
Time frame: 12 Months
Pain With Needling
Pain/discomfort during cannulation will be measured using a 10cm (0 mm to 100 mm) visual analogue scale, which ranges from "No Pain" (0 mm) on the left side to "Extreme Pain" (100 mm) on the right. The participant is instructed to place a mark on the scale according to the amount of pain felt during needling the fistula that day. The visual analogue scale with be completed at baseline, end of training, and 2 months after graduating training. The mean of these three assessments will be calculated.
Time frame: baseline, end of training (2 months), and 2 months after graduating training (4 months)
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