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

NCT05410691 | Completed

• 1 other identifier: AHEG2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• percentage of successful cannulation

  from skin contact to actual start of dialysis

Secondary Outcomes (4)

• pre-cannulation assessment time

  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

  needle to skin to end of dialysis session

• complications

  from skin contact to actual start of dialysis

Study Arms (2)

Conventional

NO INTERVENTION

AVF/AVG cannulation by renal nurses in standardised manner

ultrasound guided

ACTIVE COMPARATOR

AVF/AVG cannulation by renal nurses by handheld US device

Device: Handheld US device

Interventions

Handheld US device DEVICE

Handheld US-guided AVF/AVG cannulation

ultrasound guided

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Healthcare Group, Singapore: lead

Study Sites (1)

Allen Liu

Singapore, Singapore

Location

MeSH Terms

Conditions

Fistula; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shune Chen

  NHG, Khoo Teck Puat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: January 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)