Fully Automated Basic Life Services Resuscitation System to Improve Survival after Cardiac Arrest

摘要 该应用的总体目标是提高心脏骤停后神经系统完整的存活率 （SCA）。仍然是死亡的主要原因，在美国每年超过600，000例SCA患者中，<10%存活 神经功能良好我们建议开发和评估一种新的全面的抬头 (HUP)心肺复苏（CPR）系统主要设计用于基本生命服务（BLS） 提供者（没有护理人员的消防队员）迅速提供全自动CPR，包括第一次， 自动同步机械正压通气（PPV），以增加 SCA后神经系统完好的存活率，并增加机组人员的安全。该提案侧重于进一步发展 并基于我们在以下方面的最新突破，为BLS团队提供创新的一体化设备： 在SCA期间使用受控的头和胸的顺序抬高来优化脑灌注， 结合使用主动按压减压（ACD）CPR和阻抗阈值装置 （ITD）。如在公认的猪SCA模型中所示，HUP CPR联合ACD CPR和ITD 独特地利用重力，以加强从头部和颈部，颅内下部静脉血的引流 压力，并显着增加全身和脑血流量和生存的可能性。整体 本申请的目的也得到了来自接受CPR登记的患者的新临床数据的支持。 HUP CPR表明，这种综合方法在快速部署时可能会提供最大的益处。 此外，在全国资源紧张的紧急医疗服务（EMS）系统中， 越来越需要开发技术，以最大限度地减少提供高质量CPR所需的资源数量 这对病人的治疗效果最好，对救援人员也更安全。我们建议实现这些集体 通过证明自动正压通气（PPV），同步 到易于部署和全自动HUP CPR系统的减压阶段，对于 BLS供应商，将减少心肺复苏术人员的资源需求，最重要的是，将优化机会， 对于SCA后神经系统完整的存活率。本文中描述为SAVE CPR的这种创新组合 系统，表示同步、ACD+ITD、通风和高程的组合。因此， 具体目标是：1）设计和原型改进的抬头CPR设备，包括自动PPV 与ACD CPR的减压阶段同步; 2）确定SAVE CPR系统是否将 当在10分钟后立即实施时， 与延迟实施策略相比，未经治疗的心脏骤停，其中SAVE在10 5分钟未经治疗的心脏骤停和8分钟的常规CPR，以模拟高级生命支持（ALS） 而不是BLS部署SAVE CPR系统;以及3）测试使用SAVE CPR的可行性 BLS供应商在模拟心脏骤停情况下使用人体模型和人类尸体确定的系统 如果救援人员能够迅速部署和使用SAVE系统，并评估潜在的改进是什么 这是一个商业上可行的版本。我们期望能够展示a）整合能力 将PPV输送器械插入SAVE CPR系统B）临床前概念验证，SAVE CPR系统 与部署SAVE相比，快速部署时将显著改善猪的神经系统存活率 CPR系统经过一段时间的传统常规CPR，以及c）SAVE CPR可以轻松快速地 由BLS供应商提供。

Abstract The overall goal of this application is to improve neurologically-intact survival rates after sudden cardiac arrest (SCA). Still a leading cause of death, <10% of the more than 600,000 SCA patients in the US each year survive with favorable neurological function. We propose to develop and evaluate a novel comprehensive Head Up (HUP) cardiopulmonary resuscitation (CPR) System designed primarily to allow Basic Life Services (BLS) providers (a fire crew without paramedics) to rapidly deliver fully automated CPR, including for the first time, automated synchronized mechanical positive pressure ventilation (PPV), to increase the likelihood of neurologically intact survival after SCA and increase crew safety. The proposal focuses on further developing and delivering an innovative all-in-one device for BLS teams based on our most recent breakthroughs in optimizing brain perfusion during SCA using controlled sequential elevation of the head and thorax in combination with the use of Active Compression Decompression (ACD) CPR and an impedance threshold device (ITD). As demonstrated in a well-accepted porcine SCA model, HUP CPR combined with ACD CPR and an ITD uniquely harnesses gravity to enhance drainage of venous blood from the head and neck, lower intracranial pressure, and markedly increase systemic and cerebral blood flow and likelihood for survival. The overall objectives of this application are also supported by new clinical data from a CPR Registry of patients receiving HUP CPR suggesting this comprehensive approach may provide the most benefit when deployed rapidly. Moreover, in resource-strapped Emergency Medical Services (EMS) systems across the country there is a growing need to develop technology that minimizes the number of resources required to deliver high quality CPR that is best for patient outcomes and safer for rescue personnel. We propose to achieve these collective objectives by demonstrating that incorporation of automated positive pressure ventilation (PPV), synchronized to the decompression phase of an easy to deploy and fully automated HUP CPR system, is feasible and safe for BLS providers, will reduce CPR personnel resource requirements, and most importantly, will optimize chances for neurologically intact survival after SCA. This combination of innovations, described herein as the SAVE CPR System, represents the combination of Synchronization, ACD+ITD, Ventilation, and Elevation. As such, the Specific Aims are: 1) Design and prototype an improved Head Up CPR device which includes automated PPV that is synchronized with the decompression phase of ACD CPR; 2) Determine if the SAVE CPR System will increase 24-hour survival with favorable brain function when implemented immediately after 10 minutes of untreated cardiac arrest compared with a delayed implementation strategy whereby SAVE is initiated after 10 minutes of untreated cardiac arrest and 8 minutes of conventional CPR to simulate Advanced Life Support (ALS) rather than BLS deployment of the SAVE CPR System; and 3) Test the feasibility of use of the SAVE CPR System by BLS providers in simulated cardiac arrest scenarios using manikins and human cadavers to determine if rescuers can rapidly deploy and utilize the SAVE System and to evaluate what potential improvements are necessary for a commercially viable version. We anticipate being able to demonstrate a) the ability to incorporate a PPV delivery device into the SAVE CPR System b) pre-clinical proof-of-concept that the SAVE CPR System will significantly improve neurologically-sound survival in pigs when deployed rapidly versus deploying the SAVE CPR System after a period of traditional conventional CPR, and c) that the SAVE CPR can be easily and rapidly applied by BLS providers.