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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Fistula; Vascular Access Complication; Dialysis; Complications; Vascular Access Site Haematoma; Dialysis Access Malfunction; Graft Av
• Intervention / Treatment: Device: Handheld US device

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Allen Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Healthcare Group, Singapore
• Investigators: Principal Investigator: Shune Chen, NHG, Khoo Teck Puat Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; dialysis; haemodialysis; arteriovenous fistula; vascular access; arteriovenous graft
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Pathological Conditions, Anatomical; Fistula; Hematoma
• Other Study ID Numbers: AHEG2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No