Impedance Threshold Valve for Improving Standard CPR

描述（由申请人提供）：尽管有标准CPR，但绝大多数 心脏骤停的病人永远活不到出院。简单 需要用于提高CPR功效的有效方法。吸气 阈值阀（ITV（tm））是一种新的设备，旨在增加负 胸内压和静脉血返回心脏，从而改善 心肺复苏术中重要器官的血流它附着在面罩或呼吸器上 心肺复苏术中的插管在第一阶段，研究人员通过以下方式建立了概念证明： 证明ITVTM的使用显著增加了24小时存活率 和猪心脏骤停后的神经功能。第一阶段的结果现在 支持前瞻性、随机、设盲、院外临床试验， 本拨款提案的申请人，经FDA批准实施， (IDE：G9801 25/S3）。在第二阶段，研究人员将：1）比较重症监护 院外心脏骤停患者的住院率 接受具有活性或假ITV TM的标准CPR; 2）比较峰值 两组之间CPR期间的ETCO 2值，并回顾性相关 值与结果;以及3）比较以下子集中的关键血流动力学参数： 患者如果第二阶段取得成功，ITV TM瓣膜有可能 在美国， 一个人这种小型、廉价、轻质阀门的潜在市场规模 是很重要的它可以很容易地添加到所有现有的基本和高级生活 支持复苏设备。

DESCRIPTION (provided by applicant): Despite standard CPR, the vast majority of patients in cardiac arrest never survive to hospital discharge. Simple and effective methods for improving the efficacy of CPR are needed. The inspiratory threshold valve (ITV(tm)) is a new device designed to increase negative intrathoracic pressure and venous blood returns to the heart, thereby improving vital organ blood flow during CPR. It is attached to a face mask or breathing tube during CPR. In Phase I, investigators established proof of concept by demonstrating that use of the ITV TM significantly increased 24-hour survival and neurological function after cardiac arrest in pigs. Phase I results now support a prospective, randomized, blinded, out-of-hospital clinical trial by the applicants of this grant proposal, approved for implementation by the FDA (IDE: G9801 25/S3). In Phase II, investigators will: 1) compare intensive care unit admission rates in patients with an out-of-hospital cardiac arrest receiving standard CPR with either an active or a sham ITV TM; 2) compare peak ETCO2 values during CPR between the two groups and retrospectively correlate values with outcome; and 3) compare key hemodynamic parameters in a subset of patients. If Phase II is successful, the ITV TM valve has the potential to resuscitate approximately 50,000 more patients per year in the United States alone. The potential market size for this small, inexpensive, lightweight valve is substantial. It can be easily added to all existing Basic and Advanced Life Support resuscitation equipment.