Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
研究概览
简要总结
Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.
详细描述
Arteriovenous fistula is the lifeline of maintenance hemodialysis patients. At present, there is a lack of a simple wearable real-time evaluation technology and device for arteriovenous fistula, which can help doctors find and deal with the complications of arteriovenous fistula timely and accurately. This study proposes an innovative design based on PVDF piezoelectric membrane by combining all kinds of technologies including NB-iot/4G transmission mode to realize real-time monitoring and feedback of the health status of arteriovenous fistula vessels, so that the use time of arteriovenous fistula can be prolonged and the survival rate of dialysis patients can also be improved.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis.
- •Sign the informed consent.
排除标准
- •Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness.
- •Other circumstances deemed inappropriate by the researcher
- •Quit midway
结局指标
主要结局
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
时间窗: 2 month
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula
次要结局
未报告次要终点
研究者
Ai Peng
Director of the Department of Nephrology
Shanghai 10th People's Hospital