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

Primary Purpose

Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Handheld US device

About this trial

This is an interventional treatment trial for Hemodialysis Complication focused on measuring haemodialysis, dialysis, arteriovenous fistula, arteriovenous graft, ultrasound, vascular access

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Allen Liu

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conventional

ultrasound guided

Arm Description

AVF/AVG cannulation by renal nurses in standardised manner

AVF/AVG cannulation by renal nurses by handheld US device

Outcomes

Primary Outcome Measures

percentage of successful cannulation

Secondary Outcome Measures

pre-cannulation assessment time

time taken to assess the AVF/AVG with either US or clinical examination before cannulation

cannulation time

patients' pain score

10cm visual analogue scale

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

Full Information

NCT ID

NCT05410691

First Posted

June 5, 2022

Last Updated

June 5, 2022

Sponsor

National Healthcare Group, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT05410691

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Healthcare Group, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional

Arm Type

No Intervention

Arm Description

AVF/AVG cannulation by renal nurses in standardised manner

Arm Title

ultrasound guided

Arm Type

Active Comparator

Arm Description

AVF/AVG cannulation by renal nurses by handheld US device

Intervention Type

Device

Intervention Name(s)

Handheld US device

Intervention Description

Handheld US-guided AVF/AVG cannulation

Primary Outcome Measure Information:

Title

percentage of successful cannulation

Time Frame

from skin contact to actual start of dialysis

Secondary Outcome Measure Information:

Title

pre-cannulation assessment time

Description

time taken to assess the AVF/AVG with either US or clinical examination before cannulation

Time Frame

from patient physical contact to the time before needling thru skin

Title

cannulation time

Time Frame

skin contact by needle to succesful aspiration of blood from needle

Title

patients' pain score

Description

10cm visual analogue scale

Time Frame

needle to skin to end of dialysis session

Title

complications

Description

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

Time Frame

from skin contact to actual start of dialysis

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shune Chen

Organizational Affiliation

NHG, Khoo Teck Puat Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allen Liu

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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