Novel device for improving standard CPR outcomes

描述(由申请人提供)： 尽管基本和高级生命支持的做法很普遍，但绝大多数心脏骤停患者无法存活到出院。标准CPR固有的机械效率低下限制了即使是最熟练的救援人员的潜力。此外，绝大多数心脏骤停发生在家里，延误治疗严重限制了生存机会。因此，在最有效的紧急医疗系统中，所有院外心脏骤停的患者中，只有不到15%的人出院时神经功能完整。此外，尽管接受了标准的心肺复苏，但院外心脏骤停后到出院的平均存活率不到5%。此SBIR应用程序的目标是设计和评估一种旨在提高标准CPR效率的新型设备。该设备旨在通过让使用者有机会主动按压和主动减压来优化心脏骤停患者的循环；它将作为吸气阻抗阈值设备(ITD)的辅助治疗，这是首席研究员开发的另一项技术。这两种技术结合在一起，将在CPR减压阶段降低胸腔内压力，在胸腔内相对于身体其他部分产生真空，从而a)加强血液回流到心脏，b)加强血液回流到大脑，c)提高整体CPR效率，以及d)向救援人员提供与压缩/减压深度相关的实时反馈，以保持高质量的CPR。这项第一阶段工作的具体目标包括：1)为一种新型的主动按压减压CPR装置制作三个概念的原型，2)评估每个概念的人体工学问题并优化原型设计，以及3)通过在已建立的猪模型中评估原型的能力来建立概念证明，以验证其是否能够a)提高短期存活率和神经功能，b)增加冠脉灌注压，以及c)增加脑灌注。这些都是衡量血流动力学益处的重要指标，可以超过标准的CPR。拟议中的设备旨在供家庭和专业救援人员使用，以增加心脏骤停后有意义的存活机会。在院外心脏骤停导致的40万人死亡中，据估计，有效的主动按压减压装置与ITD相结合可以使受害者的存活机会增加5%-10%。这将导致每年增加20,000-40,000名幸存者。其目的是开发和测试一种轻量级、最终可一次性使用的原型设备，既可供专业人士使用，也可供非专业人士使用。

DESCRIPTION (provided by applicant): Despite the widespread practice of basic and advanced life support, the vast majority of patients in cardiac arrest never survive to hospital discharge. The inherent mechanical inefficiencies of standard CPR limit the potential of even the most highly skilled rescuers. Moreover, the vast majority of cardiac arrest occurs in the home and delays to treatment severely limit the chances for survival. As a result, in the most efficient emergency medical systems, less than 15% of all patients with an out-of-hospital cardiac arrest are discharged from the hospital with intact neurological function. Furthermore, the average national survival to hospital discharge after out-of-hospital cardiac arrest, despite receiving standard CPR, is less than 5%. The goal of this SBIR application is to design and evaluate a novel device designed to increase the efficiency of standard CPR. This device is intended to optimize circulation in patients in cardiac arrest by giving the user the opportunity to actively compress and actively decompress the chest wall; it will act as an adjunct therapy to the inspiratory impedance threshold device (ITD), another technology that has been developed by the principal investigator. These two technologies combined will act to decrease the intrathoracic pressure during the decompression phase of CPR, creating a vacuum within the thorax relative to the rest of the body, thereby a) enhancing blood return to the heart, b) enhancing blood return to the brain, c) improving overall CPR efficiency, and d) providing real-time feedback to rescuers related to compression/decompression depth to maintain high quality CPR. The specific aims of this Phase I effort include: 1) prototyping three concepts for a novel active compression decompression CPR device, 2) assessment of the ergonomic issues of each concept and optimize a prototype design, and 3) establishing proof of concept by evaluating the prototype in an established porcine model for its ability to a) increase the short-term survival rate and neurological function, b) increase coronary perfusion pressure, and c) increase cerebral perfusion. These are important measures of the hemodynamic benefit that can be achieved over standard CPR. The proposed device is intended for home and professional rescuer use to increase the chances for meaningful survival after cardiac arrest. Of the 400,000 deaths occurring as a result of out of hospital cardiac arrest, it is estimated that an effective active compression decompression device in combination with the ITD can increase a victim's chance of survival by 5- 10%. This would result in 20,000 - 40,000 additional survivors per year. The intent is to develop and test a lightweight and ultimately disposable prototype device that can be used by both professionals and by the lay public.