- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436559
AVF Stenosis by Electronic Stethoscope
Detection and Prediction of the Stenosis of Arteriovenous Fistula in Hemodialysis Patients by an Electronic Stethoscope
The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals.
* Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope?
This study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Taiwan
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Douliu, Taiwan, Taiwan, 640
- National Taiwan University Hospital Yunlin Branch
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent
Exclusion Criteria:
- Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AVF stenosis
Time Frame: From enrollment to the end of study at 3 months
|
Clinical stenosis: Diagnosed by attending nephrologist based on physical examination abnormalities (high-pitched bruit, pulsatile flow, diminished thrill) - Confirmed by Doppler ultrasound showing >50% diameter reduction - Intervention: Percutaneous transluminal angioplasty (PTA)
|
From enrollment to the end of study at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abnormal AVF sound threshold
Time Frame: From enrollment to the end of study at 3 months
|
Defined using statistical analysis of post-PTA normal sounds
|
From enrollment to the end of study at 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Renal Insufficiency, Chronic
- Vascular Malformations
- Fistula
- Arteriovenous Malformations
- Vascular Fistula
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Kidney Failure, Chronic
- Arteriovenous Fistula
Other Study ID Numbers
- 202302099RINA
- AVF stenosis detection (Other Identifier: National Taiwan University Hospital Yunlin Branch)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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