Point-of-care ultrasound-guided cannulation versus standard cannulation in haemodialysis vascular access: protocol for a controlled random order crossover pilot and feasibility study.

BACKGROUND: Point-of-care ultrasound (POCUS) has been used in various vascular access contexts; however, to date, it has not been widely adopted in haemodialysis clinics. People with end-stage kidney disease receiving haemodialysis require an arteriovenous fistula (AVF), arteriovenous graft (AVG), or central venous access device (CVAD) in order to access their blood for therapy/treatment. Cannulation issues, such as haematoma and extravasation, related to AVFs and AVGs are common. This pilot and feasibility study will assess the feasibility of a randomised controlled trial aimed at evaluating whether POCUS-guided cannulation results in more successful and accurate AVF needle placement than the standard practice of blind cannulation.

METHODS: A controlled, random order crossover design will be used to evaluate two clinical conditions: (1) POCUS-guided cannulation and (2) standard practice of blind cannulation, when used by haemodialysis nurses. The feasibility of conducting this type of trial for these two clinical conditions will be assessed through recruitment, retention, and attrition rates; perceptions of acceptability; implementation measures; and assessment of methods of data collection. Clinical outcomes to be assessed are overall cannulation success on first attempt, accuracy of needle tip placement, number of extravasations, procedural time, and patient and nurse perceptions. The setting is a 16-chair dialysis unit in regional Australia. Participants will include adult haemodialysis patients with an AVF in situ for greater than 2 months and haemodialysis-trained registered nurses working full- or part-time. Clinical outcomes will be analysed using generalised linear mixed models. Feasibility data will be reported using descriptive statistics. Qualitative audio data will be digitally recorded, transcribed verbatim, and analysed using thematic analysis.

DISCUSSION: Point-of-care ultrasound for cannulation has the potential to promote high-quality, safe nursing care and decrease cannulation damage for patients on haemodialysis. Due to the lack of evidence for patient benefit and its innovative and niche use in haemodialysis centres, POCUS is currently only specified in one international guideline. This study will inform sample size calculations for a future multi-site trial.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, (21/11/2017) ACTRN12617001569392.