Ultrasound Instrument to Prevent Dialysis Graft Failure

预防透析移植失败的超声波仪器

基本信息

批准号：
7452789
负责人：
David Vilkomerson
金额：
$ 9.51万
依托单位：
DVX, LLC
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-05-01 至 2008-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7452789
关键词：
Affect Applications Grants Blood Caring Characteristics Clinical Clinical Trials Control Groups Controlled Clinical Trials Current Procedural Terminology Codes Data Devices Dialysis patients Dialysis procedure Doppler Ultrasound Ensure Failure Goals Grant Health Care Costs Healthcare Systems Hemodialysis Hospitalization Intervention Measurement Measures Medical Methods Monitor Multi-Institutional Clinical Trial National Institute of Diabetes and Digestive and Kidney Diseases Numbers Operative Surgical Procedures Outcome Outcome Study Patient Monitoring Patients Phase Physical Dialysis Production Publishing Quality of life Randomized Randomized Clinical Trials Randomized Controlled Clinical Trials Readiness Research Research Ethics Committees Sensitivity and Specificity Site Small Business Funding Mechanisms Small Business Innovation Research Grant Specialist Specific qualifier value Speed Statistically Significant Structure Suggestion System Testing Thrombosis Time Ultrasonography Work base commercialization concept cost day falls graft failure hemodynamics improved innovation instrument prevent programs prototype research clinical testing size tool trial comparing

项目摘要

The aim of this program is to develop and bring to commercialization a new ultrasound Doppler device to be used to monitor the flow in dialysis access grafts. By detecting falling flow before the graft thromboses, this instrument can significantly reduce the $1 billion and thousands of days of hospitalization now caused by these graft failures. In a small group of dialysis patients, a research version of this device has been shown to be accurate while quickly measuring graft flow, and, because of its unique automatic operation, has been used by non- specialists. Because of its low cost, ease-of-use, and speed, weekly measurements of graft flow are practical, rather than the monthly intervals that other systems have required. Additionally, because the ultrasound Doppler instrument is used before the patient is connected to the dialysis machine, it is not affected by the hemodynamic changes caused by hemodialysis, nor does it interrupt the dialysis procedure, unlike other systems that have been used up to now. In this Fast Track Proposal, Phase I will validate the instrument's sensitivity and specificity in a statistically significant sized group, and test the operator-independence of the measurement. If the instrument meets the goals set in Phase I, Phase II will establish a randomized, controlled clinical trial, comparing a control group having usual care with a matched experimental group being monitored weekly with the new device. Total medical costs and hospitalization associated with the two groups will be captured and compared, with the hypothesis being tested that the monitored group will show significantly reduced access-related costs and improved quality of life, as measured by hospitalization. During Phase I and II, the research instrument will be redesigned as a small, portable unit with a PDA as the interface to the user. Production prototypes will be ready by the end of Phase II so that commercialization will be able to proceed quickly.

该计划的目的是开发一种新的超声多普勒设备并将其商业化用于监测透析通路移植物的流量。通过在移植物血栓形成之前检测流量下降，这仪器可以显着减少目前因以下原因造成的 10 亿美元和数千天的住院费用这些移植失败。在一小群透析患者中，该设备的研究版本已被证明是准确的，同时快速测量移植流量，并且由于其独特的自动操作，已被非专业人员使用专家。由于其成本低、易于使用且速度快，每周测量移植流量实用，而不是其他系统所要求的每月间隔。此外，由于超声多普勒仪器是在患者连接到超声多普勒仪器之前使用的。透析机，不受血液透析引起的血流动力学变化的影响，也不会与迄今为止使用的其他系统不同，中断透析过程。在此快速通道提案中，第一阶段将以统计方式验证仪器的灵敏度和特异性。重要大小的组，并测试测量的操作员独立性。如果仪器符合第一阶段设定的目标，第二阶段将建立一项随机对照临床试验，比较对照组每周使用新设备对匹配的实验组进行常规护理。全部的将记录并比较与两组相关的医疗费用和住院费用，正在测试的假设是，受监控组将显示与访问相关的成本显着降低，并且通过住院治疗衡量，生活质量得到改善。在第一阶段和第二阶段，研究仪器将被重新设计为小型便携式设备，并以 PDA 作为与用户的接口。生产原型将在第二阶段结束时准备就绪，以便商业化将能够快速进行。