Clinical trial NCT05410691: Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses
Official title: Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Dialysis; Complications
Vascular Access Site Haematoma
Vascular Access Complication
Dialysis Access Malfunction
Fistula
Graft Av
Keywords: haemodialysis
dialysis
arteriovenous fistula
arteriovenous graft
ultrasound
vascular access
Lead sponsor: National Healthcare Group, Singapore
Sponsor class: OTHER_GOV
First posted: 2022-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Cannulation of complex arteriovenous fistula (AVF) or graft (AVG) is a challenge to renal nurses. Ultrasound (US) guidance on central and peripheral venous access visualisation has been widely adopted in nephrology and shown to reduce complications of vascular interventions. With broader adoption of handheld US devices in clinical services, renal nurses could acquire this point-of-care technique to increase the successful cannulation rate while facilitating confidence build-up during training and practice. We aim to evaluate the use of handheld US on difficult AVF/AVG cannulation in a hospital-based dialysis unit.

Detailed description: We conducted a prospective randomised controlled study from January 2021 to January 2022. Ten renal nurses were trained by an interventional nephrologist before patient recruitment and had completed a pre- and post-training questionnaire on their confidence level. Fifty haemodialysis patients with complex AVF were randomised to US-guided or conventional cannulation. The total time spent on cannulation and patients' pain scores were also collected.

Eligibility criteria: Inclusion Criteria:

1. First-time cannulation, 2. Post-angioplasty or thrombectomy, 3. Partial stenosis confirmed with imaging or by vascular surgeons/interventional radiologists, 4. Failed cannulation by dialysis nurses at community centres, 5. Bruises or haematoma around AVF/AVG, 6. Presence of clots in AVF/AVG and 7. Deep-seated access by physical examination.

Exclusion Criteria:

complex access with a high risk of complications (calibre ≤0.4cm or vessels ≥0.8cm in depth from skin)

Primary outcomes:
measure: percentage of successful cannulation
timeFrame: from skin contact to actual start of dialysis
Secondary outcomes:
measure: pre-cannulation assessment time
timeFrame: from patient physical contact to the time before needling thru skin
measure: cannulation time
timeFrame: skin contact by needle to succesful aspiration of blood from needle
measure: patients' pain score
timeFrame: needle to skin to end of dialysis session
measure: complications
timeFrame: from skin contact to actual start of dialysis
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Allen Liu
Study officials:
affiliation: NHG, Khoo Teck Puat Hospital
name: Shune Chen
role: PRINCIPAL_INVESTIGATOR
References: