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临床试验/NCT07436559
NCT07436559已完成不适用

Detection and Prediction of the Stenosis of Arteriovenous Fistula in Hemodialysis Patients by an Electronic Stethoscope

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
AVF stenosis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent

排除标准

  • Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent

结局指标

主要结局

AVF stenosis

时间窗: 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)

次要结局

  • Abnormal AVF sound threshold(From enrollment to the end of study at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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