Ultrasound Instrument to Prevent Dialysis Graft Failure

该计划的目的是开发和商业化一种新的超声多普勒设备， 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血流， 该仪器可以显着减少10亿美元和数千天的住院治疗，现在造成的 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， 快速测量移植物流量，并且由于其独特的自动操作，已被非 专家。由于其成本低，易于使用和速度，每周测量移植物流量是 实际上，而不是其他系统所要求的每月间隔。 另外，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， 中断透析程序，不像迄今为止使用的其他系统。 在这个快速通道提案中，第一阶段将在统计学上验证仪器的灵敏度和特异性， 显著性组，并检验测量的操作者独立性。如果仪器符合 在I期设定的目标中，II期将建立一个随机、对照的临床试验， 进行常规护理，每周用新设备监测匹配的实验组。总 与两组相关的医疗费用和住院将被捕获和比较， 正在检验的假设是，受监测的群体将显示出与上网有关的费用大大减少， 改善生活质量，如住院治疗。 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， 界面到用户。生产原型将在第二阶段结束时准备就绪，以便商业化 将能够迅速进行。

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.