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

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410691
• Other study ID #: AHEG2022
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2022
• Source: National Healthcare Group, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dialysis Access Malfunction
• Dialysis; Complications
• Fistula
• Hematoma
• Hemodialysis Complication
• Vascular Access Complication

Intervention

Device:
• Handheld US device
Handheld US-guided AVF/AVG cannulation

Locations

Country	Name	City	State
Singapore	Allen Liu	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of successful cannulation		from skin contact to actual start of dialysis
Secondary	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
Secondary	cannulation time		skin contact by needle to succesful aspiration of blood from needle
Secondary	patients' pain score	10cm visual analogue scale	needle to skin to end of dialysis session
Secondary	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