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

Recruiting

• Conditions: Early Detection of Complications of Arteriovenous Fistula; Voiceprint; Arteriovenous Fistula Flow Monitoring
• Interventions: Device: A device for detecting arteriovenous fistula vascular function

• Registration Number: NCT05531825
• Lead Sponsor: Ai Peng

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-04
• Last Update Submitted: 2022-09-04
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula	2 month	Correlation between voiceprint spectrum and the blood flow of arteriovenous fistula

Trial Locations

Locations (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China