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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
Sponsored by
National Healthcare Group, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
June 5, 2022
Last Updated
June 5, 2022
Sponsor
National Healthcare Group, Singapore
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
No

Learn more about this trial

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

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