Hemodialysis ComplicationNCT05410691
Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses
A study testing Handheld US device in people with Hemodialysis Complication and Dialysis; Complications, run by National Healthcare Group, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma
- What is being tested?
- Handheld US device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- complex access with a high risk of complications (calibre ≤0.4cm or vessels ≥0.8cm in depth from skin)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses - A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma, Vascular Access Complication, Dialysis Access Malfunction, Fistula
- Being tested
- Handheld US device
- Keywords
- haemodialysis, dialysis, arteriovenous fistula, arteriovenous graft, ultrasound, vascular access
- Medical subject headings
- Fistula, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld US deviceDevice
Handheld US-guided AVF/AVG cannulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Handheld US device |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of successful cannulation
Measured: from skin contact to actual start of dialysis
Secondary outcomes (4)
pre-cannulation assessment time
time taken to assess the AVF/AVG with either US or clinical examination before cannulation
Measured: from patient physical contact to the time before needling thru skin
cannulation time
Measured: skin contact by needle to succesful aspiration of blood from needle
patients' pain score
10cm visual analogue scale
Measured: needle to skin to end of dialysis session
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
Measured: from skin contact to actual start of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Allen Liu Yan Lun, National Healthcare Group, Singapore
- Investigators
- Shune Chen, Principal investigator, NHG, Khoo Teck Puat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410691
- Sponsor's protocol ID
- AHEG2022
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handheld Ultrasound-guided Cannulation of Difficult Haemodialysis Arteriovenous Access by Renal Nurses - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05410691
- Acronym / sponsor ID
- AHEG2022
- Conditions
- Hemodialysis Complication, Dialysis; Complications, Vascular Access Site Haematoma, Vascular Access Complication, Dialysis Access Malfunction, Fistula
- Keywords
- haemodialysis, dialysis, arteriovenous fistula, arteriovenous graft, ultrasound, vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –AVF/AVG cannulation by renal nurses in standardised manner |
| ultrasound guided | Active comparator | Device: Handheld US deviceAVF/AVG cannulation by renal nurses by handheld US device |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- complex access with a high risk of complications (calibre ≤0.4cm or vessels ≥0.8cm in depth from skin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handheld US deviceHandheld US-guided AVF/AVG cannulation | Device | ultrasound guided |
Primary outcome
percentage of successful cannulation
Time frame: from skin contact to actual start of dialysis
4 secondary outcomes
pre-cannulation assessment time
Time frame: from patient physical contact to the time before needling thru skin
cannulation time
Time frame: skin contact by needle to succesful aspiration of blood from needle
patients' pain score
Time frame: needle to skin to end of dialysis session
complications
Time frame: from skin contact to actual start of dialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shune Chen principal investigator
NHG, Khoo Teck Puat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld US device in people with Hemodialysis Complication and Dialysis; Complications, run by National Healthcare Group, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of successful cannulation (time frame: from skin contact to actual start of dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.