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Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access

Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06381310
Enrollment
50
Registered
2024-04-24
Start date
2024-02-26
Completion date
2024-10-30
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Successful Cannulation

Brief 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. 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.

Interventions

DEVICEasus-handheld-ultrasound LU710L

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.

Sponsors

National Taiwan University Hospital Bei-Hu Branch
CollaboratorUNKNOWN
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

1. Those who can undergo the first arteriovenous canal puncture after being evaluated by a physician more than 8 weeks after surgery. 2. The puncture has failed more than 2 times, and there are bruises or hematomas around the arteriovenous and venous vessels. 3. 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. 4. The patient has clear consciousness and normal cognitive and communication abilities.

Exclusion criteria

1. Under 20 years old. 2. 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).

Design outcomes

Primary

MeasureTime frame
cannulation success rate12 times

Secondary

MeasureTime frameDescription
cannulation satisfaction12 timesConduct 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.

Countries

Taiwan

Contacts

Primary ContactTsuei-Wun Chang
f961153@gmail.com886-919225838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026