Clinical Study on Integrating ASafe: A Novel Hemostasis Device with Time Alert and Acoustic Analysis in Hemodialysis Care
No. APCN20250356
Clinical Study on Integrating ASafe: A Novel Hemostasis Device with Time Alert and Acoustic Analysis in Hemodialysis Care
LU CHARNG-LEH1; Mei-Ju Su1; JENQ-WEN HUANG2; Yen-Ni Hung3
| 1 Department of Biomedical Engineering, Chung Yuan Christian University, Taiwan |
| 2 Department of Internal Medicine, National Taiwan University Hospital, Taiwan |
| 3 Taiwan Medical Intelligent Ltd, Taiwan |
Abstract
Introduction
In Taiwan, over 90,000 end-stage renal disease (ESRD) patients rely on hemodialysis, with over 90% using long-term hemodialysis via arteriovenous fistulas (AVFs) or arteriovenous grafts (AV grafts) as vascular access. Vascular access is critical to both treatment quality and patient survival. However, improper post-dialysis hemostasis can lead to various complications, adversely impacting patient outcomes and increasing the burden on healthcare resources. Direct pressure requires over 10 minutes of vertical compression to stop bleeding while preserving vascular access. Tourniquets, applied at 20-30 mmHg above systolic pressure, can impede venous return and risk pseudoaneurysm formation due to parallel pressure distribution. Literature indicates that direct pressure is the preferred post-dialysis hemostasis method due to fewer complications and shorter compression times compared to tourniquets. However, it may increase clinical workload when nurse-assisted compression is needed. Related literature attributes improper hemostasis often due to inadequate technique or knowledge, poor compression practices, and ineffective tools. Improvements include education, standardized materials, and rotating puncture sites. Studies have shown that blood flow generates vibrations, particularly in stenotic areas, which produce detectable acoustic signals. These signals reflect physiological properties and may facilitate early identification of vascular access dysfunction. However, studies on device-based interventions remain limited. This study evaluates a novel wearable device, ASafe, which integrates tourniquet, time alert, and audio recording to assess its effectiveness in vascular access management for hemodialysis patients.
Methods
This study involves a randomized clinical trial conducted in collaboration with a hemodialysis clinic in northern Taiwan. A pre- and post-intervention study will be conducted to compare patients using the ASafe device and those receiving traditional hemostasis methods (such as direct pressure or tourniquet), in order to evaluate clinical effectiveness, adverse reactions, and satisfaction with the intervention. Acoustic signals from vascular access will be analyzed to develop an automated classification model for different stages of vascular access conditions.
Results
Preliminary findings and initial model development indicate that the ASafe device offers more accurate tourniquet time, fewer adverse events, and higher patient satisfaction. Superior outcomes are also expected for vascular access function with the ASafe device.
Conclusion
The use of the ASafe device may enhance vascular access management, reduce complications, and support clinical decision-making, thereby improving the quality of hemodialysis care. This study highlights the potential of smart healthcare technologies in advancing dialysis outcomes and promoting patient well-being.
Keywords：Hemodialysis, Vascular Access, Vascular Access Management