Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses - A Randomised Controlled Trial

Conditions
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Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma, Vascular Access Complication, Dialysis Access Malfunction, Fistula, Graft Av

Intervention / Treatment
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* Device: Handheld US device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional<br>AVF/AVG cannulation by renal nurses in standardised manner | |
| Active Comparator: ultrasound guided<br>AVF/AVG cannulation by renal nurses by handheld US device | Device: Handheld US device<br>* Handheld US-guided AVF/AVG cannulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of successful cannulation |  | from skin contact to actual start of dialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-cannulation assessment time | time taken to assess the AVF/AVG with either US or clinical examination before cannulation | from patient physical contact to the time before needling thru skin | 
| cannulation time |  | skin contact by needle to succesful aspiration of blood from needle | 
| patients' pain score | 10cm visual analogue scale | needle to skin to end of dialysis session | 
| complications | need for a temporary central venous catheter, single-needle dialysis, or infiltration (e.g. haematoma) that hastened the use of AVF/AVG for the same dialysis session | from skin contact to actual start of dialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemodialysis, dialysis, arteriovenous fistula, arteriovenous graft, ultrasound, vascular access