Phase II, Head Up Cardiopulmonary Resuscitation Device

第二阶段，平视心肺复苏装置

• 批准号: 10325222
• 负责人: Keith Lurie
• 金额: $ 106.94万
• 依托单位: MINNESOTA RESUSCITATION SOLUTIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-17 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325222
• 关键词: 911 call; Adoption; Adult; Age; American; Animals; Automated External Defibrillator; Basic Life Support; Biochemical Markers; Blood; Blood Circulation; Blood flow; Brain; Brain Injuries; COVID-19; Cadaver; Cardiac Output; Cardiopulmonary Resuscitation; Caring; Cause of Death; Cerebral perfusion pressure; Cerebrovascular Circulation; Cerebrum; Cessation of life; Chest; Chest wall structure; Clinical; Communities; Critiques; Development; Devices; Electric Countershock; Exposure to; Extracorporeal Membrane Oxygenation; Family suidae; Force of Gravity; Funding; Goals; Hand; Head; Heart; Heart Arrest; Home; Hospitals; Hour; Human; Human Resources; Imaging Techniques; Infection; Intracranial Pressure; Life; Magnetic Resonance Imaging; Manikins; Manuals; Measurement; Methods; Monitor; Moon; Nervous System Physiology; Neurologic; Outcome; Oxygen saturation measurement; Patients; Pharmaceutical Preparations; Phase; Physiological; Police; Positioning Attribute; Poverty; Refractory; Resuscitation; Risk; Safety; Seeds; Shock; Small Business Innovation Research Grant; Suction; Survival Rate; System; Testing; Time; Training; United States; Venous; Ventricular Fibrillation; War; Weight; Work; base; cerebral oxygenation; clinical care; coronary perfusion; coronavirus disease; design; electric impedance; fire fighter; first responder; hemodynamics; improved; innovation; innovative technologies; insight; men; new technology; next generation; novel; porcine model; portability; pre-clinical; preclinical study; pressure; success; transmission process; treatment strategy; ventilation

Abstract Sudden cardiac arrest (SCA) is a leading cause of death in the USA, with only 3-20% neurologically intact survival for >350,000 out-of-hospital SCA patients each year. Even after patients are initially resuscitated, many die within a week from severe brain injury. The goal of this application is to improve neurologically-intact survival rates after pre-hospital and in-hospital SCA. The Phase I pre-clinical studies showed 1) elevation of the head and thorax during active compression decompression (ACD) CPR with an impedance threshold device (ITD) doubled brain blood flow versus ACD+ITD CPR in the flat position and, 2) controlled and sequential head and thorax elevation with ACD+ITD CPR resulted in a 6-fold increase in neurologically-intact survival versus conventional CPR in the flat position. This novel method of CPR is called Head Up Position (HUP) CPR. It works by harnessing gravity to enhance venous blood flow from the brain to the heart, lower intracranial pressure, and enhance cardiac output. The first human HUP CPR device, the EleGARDTM, was designed, built, and tested with Phase I funding support. The EleGARD subsequently received FDA 510k clearance and has been used to help treat >400 SCA patients to date. Based upon these positive outcomes, the Phase II objectives are to 1) Design, develop, and build an improved EleGARD-2 to accelerate time to device application and increase adoption rates through a) a reduction in size and weight and an improved user interface, b) addition of regional cerebral oximetry (rSO2) and, c) incorporation of automated positive pressure breath delivery to increase crew safety in the age of Covid-19; 2) Demonstrate neurologically-intact survival is superior with ACD+ITD HUP CPR versus ACD+ITD CPR flat in a pig model that includes salvage with extra-corporeal membrane oxygenation (ECMO) to evaluate the potential benefit of HUP CPR with the rapidly evolving use of ECMO for SCA; and 3) Demonstrate HUP CPR utilizing EleGARD-2 reduces brain injury in a pig model of SCA utilizing advanced imaging techniques. The next generation HUP CPR device will be easier to store, carry, and deploy, will provide rSO2 to better guide care, and provide automated breath delivery to increase crew safety and reduce the number of rescuers needed to perform CPR. The animal studies will help determine the potential for HUP CPR to extend physiologic viability during resuscitation in refractory ventricular fibrillation until better hemodynamic support in the form of ECMO is available, and help determine if HUP CPR reduces brain injury, as determined by MRI and measurement of biochemical markers. Collectively, Phase II funding will support the development of the next generation HUP CPR platform and accelerate adoption of this innovative technology to improve neurologically-intact survival rates after SCA.

抽象的 心脏骤停 (SCA) 是美国的主要原因，只有 3-20% 的患者神经系统完好 每年超过 350,000 名院外 SCA 患者的生存率。即使在患者最初复苏后，许多人 一周内死于严重脑损伤。该应用程序的目标是提高神经完整的存活率 院前和院内 SCA 后的发生率。 I 期临床前研究表明 1) 头部抬高 使用阻抗阈值装置 (ITD) 进行主动加压减压 (ACD) 心肺复苏期间的胸部和胸部 与平躺位置的 ACD+ITD CPR 相比，脑血流量增加了一倍，2) 受控且连续的头部和 与 ACD+ITD CPR 相比，胸部抬高导致神经完整存活率增加 6 倍 平躺位置的常规心肺复苏。这种新颖的心肺复苏方法称为抬头位 (HUP) 心肺复苏。有用 通过利用重力来增强从大脑到心脏的静脉血流量，降低颅内压， 增强心输出量。第一个人类 HUP CPR 设备 EleGARDTM 的设计、制造和测试 第一期资金支持。 EleGARD 随后获得 FDA 510k 许可，并已用于帮助 迄今为止，已治疗超过 400 名 SCA 患者。基于这些积极成果，第二阶段的目标是 1) 设计、 开发并构建改进的 EleGARD-2，以加快设备应用时间并提高采用率 通过 a) 减小尺寸和重量并改进用户界面，b) 增加区域脑血氧饱和度 (rSO2) 和，c) 结合自动正压呼吸输送，以提高船员的安全 新冠肺炎; 2) 证明 ACD+ITD HUP CPR 的神经完整存活率优于 ACD+ITD 猪模型中的心肺复苏 (CPR) 平坦，包括使用体外膜氧合 (ECMO) 进行抢救以进行评估 随着 ECMO 在 SCA 中的快速发展，HUP CPR 的潜在优势； 3) 演示 HUP 心肺复苏 利用先进的成像技术，EleGARD-2 可减少 SCA 猪模型的脑损伤。下一个 新一代 HUP CPR 设备将更容易存储、携带和部署，将提供 rSO2 来更好地指导护理， 并提供自动呼吸输送，以提高船员安全并减少救援人员数量 进行心肺复苏。动物研究将有助于确定 HUP CPR 延长生理活力的潜力 在难治性心室颤动的复苏期间，直到以 ECMO 形式提供更好的血流动力学支持 可用，并帮助确定 HUP CPR 是否可以减少脑损伤（通过 MRI 和测量来确定） 生化标记。总的来说，第二阶段的资金将支持下一代 HUP 的开发 心肺复苏平台并加速采用这一创新技术，以改善神经完整的生存率 SCA 后的利率。