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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）：长期透析的成功和成本取决于维持患者的血管通路，这是通过手术创建的动静脉旁路区域，可以允许高血流量。在透析过程中，血液从通路动脉侧的针中抽取，通过血液透析装置过滤，然后通过第二个下游针返回患者体内。血管通路也被称为血液透析的“致命弱点”，因为保持高流量特征（通路通畅）对于实现有效的透析治疗至关重要。对血管通路进行监测和监视，以识别可能导致通路阻塞（血栓形成）的内部狭窄（狭窄）。通路监测的目的是在血栓形成之前通过常规外科手术预防性治疗狭窄。当前的通路监测依赖于熟练的操作员和专业设备，由于血液透析护理标准内的经济现实，无法有效地应用于所有患者。我们提出临床实验来证明和评估血液透析血管通路通畅性非侵入性筛查的新方法。我们有兴趣研究使用数字听诊器和皮肤温度测量自动收集血管信号的可行性，以提供动静脉移植物通畅性的连续实时测量。我们将进行这项研究，以回答有关这种非侵入性监测方法的可重复性和可行性的假设，并展示创新技术以实现临床应用。这项工作的第二个目标是培训 Steve Majerus 成为一名能够研究血管健康技术未来方向的独立研究员。我们的研究计划将通过两个目标进行。目标 1 将在克利夫兰弗吉尼亚州市中心血液透析中心进行一项临床研究，其中将使用数字听诊器和红外 (IR) 温度计收集患者血管通路附近的非侵入性信号。这些信号已被证明是访问通畅性的准确指标；我们试图了解患者之间以及慢性透析患者内部的信号特征和变异性。目标 2 将确定使用无线电子设备无创测量血管声音和皮肤温度的可行性。这是了解该方法的再现性和可变性的重要实验。为了对超负荷透析诊所的现实产生影响，测量方法必须易于使用且在非医生使用时准确。将评估所提出的无线方法的局限性，以确定原型的可行性和未来的方向。本研究旨在进行假设驱动的研究，同时在血管信号分析和无线可穿戴传感器设计领域产生创新的平台技术。与血管通路狭窄程度和位置相关的血管造影和皮肤温度测量的综合分析尚未发表。已发布的无线筛查工具示例依赖于熟练操作员的传统听诊。我们寻求证明适合临床部署的最先进的电子和传感器集成技术的可行性。该技术将是临床转化的绝佳候选者，因为它可以在独立透析诊所的经济限制内实现血管通路通畅性的简单筛查。