Ultrasound Instrument to Prevent Dialysis Graft Failure

描述（由申请人提供）： 该项目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中的流量。通过在移植物血栓形成之前检测下降的流量，该仪器可以显着减少10亿美元和数千天的住院治疗，现在这些移植失败造成的。在一小组透析患者中，该设备的研究版本已被证明在快速测量移植物流量时是准确的，并且由于其独特的自动操作，已被非专业人员使用。由于其成本低，易于使用和速度，每周测量移植物流量是可行的，而不是其他系统所需的每月间隔。此外，由于超声多普勒仪器是在患者与透析机连接之前使用的，因此不受血液透析引起的血液动力学变化的影响，也不会中断透析过程，这与迄今为止使用的其他系统不同。在这个快速通道提案中，第一阶段将在统计学上显著的规模组中验证仪器的灵敏度和特异性，并测试测量的操作员独立性。如果仪器达到了第一阶段设定的目标，第二阶段将建立一个随机对照临床试验，比较一个对照组和一个匹配的实验组，对照组接受常规护理，每周使用新设备进行监测。将采集并比较两组相关的总医疗费用和住院费用，并检验以下假设：受监测组将显示出显著降低的接入相关费用和改善的生活质量（通过住院来衡量）。在第一和第二阶段，研究仪器将重新设计为一个小型便携式装置，并以PDA作为用户界面。生产原型将在第二阶段结束时准备就绪，以便能够快速进行商业化。

DESCRIPTION (provided by applicant): 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.