IMPEDANCE THRESHOLD VALVE FOR IMPROVING STANDARD CPR

院外心脏骤停和标准心肺复苏术后的全国平均存活率不到5%。需要简单有效的方法来提高心肺复苏术的疗效。吸气阻抗阈值阀（ITV）是一种创新装置，旨在通过增加胸内负压和静脉血返回心脏来显著提高标准CPR的有效性。ITV的初步动物研究表明，在动物模型中，标准CPR期间重要器官灌注增加100%，脑血流正常化。本1期研究建议：a)通过对瓣膜进行生物工程设计变更和评估，提高ITV的安全性和效率；b)在猪心脏骤停模型的标准CPR期间，通过评估有或没有ITV的神经系统完整存活率和肺部并发症发生率，确定概念的证明。如果成功，二期研究将探讨ITV在院外心脏骤停患者中的潜在临床疗效。根据在动物实验中观察到的心脏和大脑血流量的改善，ITV的使用有望使患者复苏率提高25-50%。如果有显著的临床效果，ITV将成为所有接受心肺复苏术的心脏骤停患者的标准复苏设备。拟议的商业应用：由于以下几个因素，Resusci-Valve ITV具有重要的全球市场和商业化潜力：其创新品质，低成本，易于使用，只需最少的培训，以及与任何标准呼吸电路的兼容性。ITV的潜在市场规模是巨大的，因为仅在美国每年就有至少75万名心脏骤停患者接受治疗。ITV可以很容易地添加到所有现有的基本和高级生命支持复苏设备。

The average national survival rate after out-of-hospital cardiac arrest and standard CPR is less than 5%. Simple and effective methods for improving the efficacy of CPR are needed. The inspiratory impedance threshold valve (ITV) is an innovative device designed to significantly increase the effectiveness of standard CPR in patients by increasing negative intrathoracic pressure and venous blood return to the heart. Preliminary animal studies with the ITV demonstrate up to 100% increase in vital organ perfusion and normalization of cerebral blood flow during standard CPR in an animal model. This phase 1 investigation proposes to a) improve the safety and efficiency of the ITV by making and evaluating bioengineering design changes in the valve and b) determine proof of concept by assessing neurologically intact survival rates and pulmonary complication rates with and without the ITV during standard CPR in a porcine model of cardiac arrest. If successful, the phase 2 studies will address the potential clinical efficacy of the ITV in patients with out-of-hospital cardiac arrest. Use of the ITV is expected to increase patient resuscitation rates by 25-50%, based upon the improvement in blood flow to the heart and brain observed in animal studies. If a significant clinical benefit is demonstrated, the ITV would become a standard piece of resuscitation equipment for all patients in cardiac arrest who receive CPR. PROPOSED COMMERCIAL APPLICATIONS: The Resusci-Valve ITV has significant worldwide market and commercialization potential due to several factors including: its innovative qualities, low cost, ease of use with minimal training, and compatibility with any standard breathing circuit. The potential market size for the ITV is substantial as there are at least 750,000 patients treated for cardiac arrests per year in the United States alone. The ITV can be added easily to all existing Basic and Advanced Life Support resuscitation equipment.