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

NCT ID: NCT05410691

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional

AVF/AVG cannulation by renal nurses in standardised manner

Group Type NO_INTERVENTION

No interventions assigned to this group

ultrasound guided

AVF/AVG cannulation by renal nurses by handheld US device

Group Type ACTIVE_COMPARATOR

Handheld US device

Intervention Type DEVICE

Handheld US-guided AVF/AVG cannulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Handheld US device

Handheld US-guided AVF/AVG cannulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Healthcare Group, Singapore

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Allen Liu Yan Lun

Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shune Chen

Role: PRINCIPAL_INVESTIGATOR

NHG, Khoo Teck Puat Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Allen Liu

Singapore, , Singapore

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Singapore

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AHEG2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.