Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function

Study Overview
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Brief Summary
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Evaluation on the reliability, practicability and safety of a wearable device for measuring arteriovenous fistula function based on voice print.

Detailed Description
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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.

Official Title
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Clinical Evaluation Study of a Device for Detecting Arteriovenous Fistula Vascular Function

Conditions
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Arteriovenous Fistula Flow Monitoring, Early Detection of Complications of Arteriovenous Fistula, Voiceprint

Intervention / Treatment
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* Device: A device for detecting arteriovenous fistula vascular function


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75. Patients diagnosed with end-stage renal failure and planning to undergo venous fistula surgery or maintenance hemodialysis. Sign the informed consent. Exclusion Criteria: Pregnant and lactating women, bipolar disorder, schizophrenia and other serious mental illness. Other circumstances deemed inappropriate by the researcher Quit midway

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal control group<br>Patients with no disease in the main organs, with well-developed body shape, and with good physiological functions, physical activity abilities and labor abilities. | Device: A device for detecting arteriovenous fistula vascular function<br>* 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<br>|
| Newly established arteriovenous fistula group<br>Chronic kidney disease stage 5 (CKD5) non-dialysis patients planning to undergo internal arteriovenous fistula surgery. | Device: A device for detecting arteriovenous fistula vascular function<br>* 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<br>|
| reconstructed arteriovenous fistula group<br>Patients with maintenance hemodialysis who need to reconstruct the internal arteriovenous fistula on account of dissatisfaction with blood flow. | Device: A device for detecting arteriovenous fistula vascular function<br>* 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<br>|
| Long-term maintenance hemodialysis group<br>Patients undergoing hemodialysis with long-term fixed internal arteriovenous fistula. | Device: A device for detecting arteriovenous fistula vascular function<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula | Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula | 2 month |