Real-Time Monitoring Device for Vascular Signals

血管信号实时监测装置

基本信息

批准号：
9241893
负责人：
Steve Majerus
金额：
--
依托单位：
LOUIS STOKES CLEVELAND VA MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-03-01 至 2018-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9241893
关键词：
Address Algorithms Angiography Angioplasty Arteries Arteriovenous fistula Auscultation Award Basic Science Blood Blood Vessels Blood flow Bypass Caring Characteristics Chronic Clinic Clinical Clinical Research Collection Contralateral Custom Data Development Dialysis patients Dialysis procedure Economics Electronics Equipment Exposure to Failure Feasibility Studies Fistula Floor Foundations Frequencies Funding Future Goals Gold Health Health Technology Hemodialysis Home environment Hospitals Human Human Resources Human Volunteers Institutional Review Boards Interventional radiology Kidney Failure Lead Location Longevity Maintenance Measurement Measures Methods Miniaturization Modality Modeling Monitor Morbidity - disease rate Needles Noise Operative Surgical Procedures Outcome Patients Performance Peripheral Phase Physicians Principal Component Analysis Process Protocols documentation Publications Publishing Quality of Care Recruitment Activity Reproducibility Research Research Personnel Risk Sampling Sensory Side Signal Transduction Skin Temperature Stenosis Stethoscopes Surveillance Program Techniques Technology Testing Thermometers Thrombosis Time Training United States National Institutes of Health Vascular Patency Veins Veterans Visit Wireless Technology Work arm base career checkup examination clinical application clinical candidate clinical practice clinical translation cost design digital equipment training experimental study graft healing inclusion criteria innovation innovative technologies interest man mathematical analysis monitoring device mortality non-invasive monitor novel novel strategies patient population programs prospective prototype public health relevance repaired research clinical testing response restenosis screening sensor sound standard of care success tool translational impact transmission process trend

项目摘要

DESCRIPTION (provided by applicant): Long-term dialysis success and cost is dependent on maintaining a patient's vascular access, a surgically- created artery-vein bypass region that can permit high blood flow. During dialysis, blood is drawn from a needle in the arterial side of the access, filtered by a hemodialysis unit, and then returned to the patient through a second downstream needle. The vascular access is also known as the "Achilles Heel" of hemodialysis, as maintaining the high flow characteristics (access patency) is critical to achieving efficient dialysis treatment. Vascular accesses are subjected to monitoring and surveillance to identify internal narrowing (stenosis) which can lead to access blockage (thrombosis). The goal of access monitoring is to pre- emptively treat stenosis with a routine surgical procedure before thrombosis occurs. Current access monitoring relies on skilled operators and specialized equipment and cannot be effectively applied to all patients due to economic realities within the hemodialysis standard-of-care. We propose clinical experiments to demonstrate and evaluate new approaches for non-invasive screening of hemodialysis vascular access patency. We are interested in studying the feasibility of autonomously gathering vascular signals using digital stethoscopes and skin temperature measurements to provide a continuous and real-time measure of arteriovenous graft patency. We will pursue this research to answer hypotheses regarding the reproducibility and feasibility of this non-invasive monitoring method, and to demonstrate innovative technology to enable clinical application. A second objective of this work is to train Steve Majerus to be an independent researcher capable of investigating future directions for vascular health technology. Our research plan will be conducted through two objectives. Objective 1 will conduct a clinical study at the Cleveland VA Midtown Hemodialysis Center in which digital stethoscopes and infrared (IR) thermometers will be used to gather non-invasive signals near patient's vascular accesses. These signals have been shown to be accurate indicators of access patency; we seek to understand the signal characteristics and variability across patients and within patients on chronic dialysis. Objective 2 will determine the feasibility of non-invasively measuring vascular sounds and skin temperatures using wireless electronics. This is an important experiment to understand the reproducibility and variability of this approach. To make an impact within the realities of over-loaded dialysis clinics, the measurement method must be convenient to use and accurate when used by a non-physician. The limitations of the proposed wireless approach will be assessed to determine prototype feasibility and future directions. This study aims to pursue hypothesis-driven research while producing innovative platform technologies in the fields of vascular signal analysis and wireless, wearable sensor design. A comprehensive analysis of phonoangiograms and skin temperature measurements relative to vascular access stenosis level and location has not yet been published. Published examples of wireless screening tools have relied on traditional auscultation via a skilled operator. We seek to demonstrate the feasibility of state-of-the-art electronics and sensor integration technology that is suitable for clinical deployment. This technology would be an excellent candidate for clinical translation as it could enable simple screening of vascular access patency within the economic constraints of freestanding dialysis clinics.

描述（由申请人提供）：长期的透析和成本取决于患者的血管中的高血流量，因为保持高流量特征（访问通畅）对于实现效率治疗至关重要。通过常规的手术，在血栓形成之前就依靠熟练的操作员和专门的设备，并且由于体重分析的经济现实而无法应用于所有患者。我们有兴趣使用数字听诊器和皮肤温度测量来研究自主收集血管信号，这是一种连续的，实时的，对动脉移植的静脉注射量。这种非侵入性监测方法，并证明了能够调查ES的未来方向的临床研究人员。温度计将在患者的血管访问附近收集非侵入性信号。使用无线电子的血管声音和皮肤温度。这项研究旨在在Vasculn Al Anal Analy和Wireless领域生产创新的平台技术，对手机Noangiigraph lar访问狭窄水平进行全面分析，并且尚未公布位置。适用于临床部署的艺术电子和感官综合学是秘密的出色候选者，因为它可以简单地在G透析诊所的经济结构内简单地进行尖锐的访问Pascular访问。