Successful CannulationNCT06381310
Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access
A study testing asus-handheld-ultrasound LU710L in people with Successful Cannulation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Successful Cannulation
- What is being tested?
- asus-handheld-ultrasound LU710L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2024to 30 Oct 2024
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who can undergo the first arteriovenous canal puncture after being evaluated by a physician more than 8 weeks after surgery.
- The puncture has failed more than 2 times, and there are bruises or hematomas around the arteriovenous and venous vessels.
- Arteriovenous and venous ducts Ultrasonic detection of arteriovenous and venous ducts ≧0.4, the depth of blood vessels from the skin is 0.4-0.7 cm.
- The patient has clear consciousness and normal cognitive and communication abilities.
Who cannot join
- Under 20 years old.
- Complex pathways assessed by physicians as having a high risk of complications (diameter ≤ 0.4 cm or depth of blood vessel from skin ≥ 0.8 cm).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Bei-Hu Branch
Taipei
Tsuei-Wun Chang, 886-23717101 ext. 218501
About this study
Official title: Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access: A Randomized Controlled Trial
Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.
Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.
Read more
Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.
Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care.
- Conditions
- Successful Cannulation
- Being tested
- asus-handheld-ultrasound LU710L
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asus-handheld-ultrasound LU710LDevice
Ultrasound-guided group:The nurse uses ultrasound-guide injection. control group: After physical assessment by the nurse, the injection will be carried out according to the conventional injection plan.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided group | Experimental | Not described Receives: Device: asus-handheld-ultrasound LU710L |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
cannulation success rate
Measured: 12 times
Secondary outcomes (1)
cannulation satisfaction
Conduct a survey using a self-designed satisfaction questionnaire.Assess satisfaction using Likert scoring criteria. Rate satisfaction on a scale of 0 to 5, with 5 being the highest and 0 being the lowest.
Measured: 12 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start26 Feb 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Successful CannulationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital Beihu Branch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381310
- Sponsor's protocol ID
- 202310077DINB
- Status last verified
- Feb 2024
- First submitted
- 9 Apr 2024
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06381310
- Acronym / sponsor ID
- 202310077DINB
- Conditions
- Successful Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital Beihu Branch
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 24 Apr 2024 (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.
Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.
Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.
Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.
Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided group | Experimental | Device: asus-handheld-ultrasound LU710L |
| control group | No intervention | – |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who can undergo the first arteriovenous canal puncture after being evaluated by a physician more than 8 weeks after surgery.
- The puncture has failed more than 2 times, and there are bruises or hematomas around the arteriovenous and venous vessels.
- Arteriovenous and venous ducts Ultrasonic detection of arteriovenous and venous ducts ≧0.4, the depth of blood vessels from the skin is 0.4-0.7 cm.
- The patient has clear consciousness and normal cognitive and communication abilities.
Key exclusion criteria (2 listed)
- Under 20 years old.
- Complex pathways assessed by physicians as having a high risk of complications (diameter ≤ 0.4 cm or depth of blood vessel from skin ≥ 0.8 cm).
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 |
|---|---|---|
| asus-handheld-ultrasound LU710LUltrasound-guided group:The nurse uses ultrasound-guide injection. control group: After physical assessment by the nurse, the injection will be carried out according to the conventional injection plan. | Device | Ultrasound-guided group |
Primary outcome
cannulation success rate
Time frame: 12 times
1 secondary outcome
cannulation satisfaction
Time frame: 12 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Successful Cannulation
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Active, not recruiting
Handheld US Device to Verify Vascular Cannulation
Surgery
Active, not recruiting
Biplanar Handheld Ultrasound for Transradial Artery Puncture
Radial Artery Cannulation
Not yet recruiting
Comparison of Short-Axis and Long-Axis Internal Jugular Vein Cannulation for First-Pass Success
Cannulation of Internal Jugular Vein
Recruiting
The Effect of Near-infrared Spectroscopy on the Success of Peripheral Venous Access
Intravenous Cannulation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asus-handheld-ultrasound LU710L in people with Successful Cannulation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Apr 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsuei-Wun Chang (886-919225838, f961153@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cannulation success rate (time frame: 12 times). 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 24 Apr 2024.