A Multimodal Integrated System For Improved Cardiopulmonary Resuscitation

用于改善心肺复苏的多模式集成系统

• 批准号: 10546620
• 负责人: HENRY R HALPERIN
• 金额: $ 59.74万
• 依托单位: CPR THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10546620
• 关键词: Abdomen; Address; Adhesives; Basic Science; Beds; Blood Circulation; Blood flow; Brain; Cardiac Output; Cardiopulmonary Resuscitation; Cause of Death; Chest; Clinical; Computers; Counterpulsation; Data; Development; Devices; Electric Countershock; Electrophysiology (science); Engineering; Failure; Family suidae; Funding; Generations; Hand; Heart; Heart Arrest; Human; Human Resources; Impaired cognition; Impairment; Individual; Injury; Investigation; Knowledge; Left; Manuals; Mechanics; Medical; Medical Device; Modeling; Modernization; Neurologic; Organ; Outcome; Patient-Focused Outcomes; Patients; Pattern; Performance; Perfusion; Phase; Pilot Projects; Provider; Pump; Residual state; Resuscitation; Safety; Science; Series; Speed; Survival Rate; System; Techniques; Technology; Testing; Therapeutic; Time; Training; Trapezoid bone structure; United States; Venous; Ventricular Fibrillation; Ventricular Function; Work; base; cardiopulmonary system; constriction; design; feasibility trial; first-in-human; hemodynamics; improved; improved outcome; innovation; millisecond; multimodality; out-of-hospital cardiac arrest; porcine model; portability; precision medicine; programs; prototype; randomized trial; safety and feasibility; skeletal injury; societal costs; standard of care; success; technology development

Abstract CPR Therapeutics Inc. is developing the first multimodal automated system for cardiopulmonary resuscitation (CPR). This technology integrates and synchronizes multiple pump-mechanisms with enhanced defibrillation, and will be the first device to improve outcomes of patients in cardiac arrest with a number-needed- to-treat predictive of commercial success. It will do this while enhancing patient and provider safety. Nationally, approximately 650,000 individuals suffer cardiac arrest each year. Fifty years after the description of CPR, survival is generally below 10%, and a significant fraction of resuscitated patients are left with neurologic impairment. Remarkably, the standard-of-care remains manual chest compressions performed by rescuers with their hands. It has been estimated that the societal costs related to out-of-hospital cardiac arrest alone may be in excess of $33 billion a year in the US. Without question, clinically effective improvements in CPR are among the greatest unmet medical needs. All previous attempts at effective CPR devices have: 1) focused on only one enhancement at a time, 2) had disappointing outcomes in randomized trials, 3) cause skeletal injuries in most patients, and 4) provide no benefit over manual CPR. In a series of pilot studies, CPR Therapeutics demonstrated that combinations of cardiac output- and venous return-enhancing techniques may offer additive or even synergistic benefits to hemodynamics. As envisioned, the Company’s multifunctional system is based on the concept that multiple CPR pump mechanisms, combined with synchronization of defibrillation and pulseless electrical activity (PEA) CPR, will synergize both the hemodynamics and electrophysiology. These approach should significantly improve real-world clinical outcomes. In this Direct-to-Phase II project, CPR Therapeutics will: 1) Design and build a 3rd generation porcine test-bed capable of high-fidelity millisecond control of the multimodal CPR pump-mechanisms, 2) Optimize the system configuration and component designs in a porcine model of ventricular fibrillation, and 3) Design and build a human clinical prototype under a design-control and Quality Management System (QMS). This device will be subjected to structural and functional bench testing in anticipation of filing for an FDA IDE. In addition to the development of the technology, the project’s scope-of- work will add significantly to our basic science knowledge of the interactions between CPR pump-mechanisms and patient-component synchronizations.

抽象的 CPR Therapeutics Inc. 正在开发第一个心肺多模式自动化系统 该技术集成并同步增强的多个泵机制。 除颤，并将成为第一个改善心脏骤停患者预后的设备，其数量需要- 它将在全国范围内提高患者和提供者的安全性的同时进行治疗预测。 心肺复苏 (CPR) 出现 50 年后，每年约有 65 万人遭受心脏骤停。 存活率通常低于 10%，并且很大一部分复苏的患者仍患有神经系统疾病 值得注意的是，护理标准仍然是由救援人员进行手动胸外按压。 据估计，仅与院外心脏骤停相关的社会成本就可能是 美国每年花费超过 330 亿美元，毫无疑问，CPR 的临床有效改进就是其中之一。 之前对有效心肺复苏设备的最大未满足的医疗需求是：1）仅集中于一个。 一次增强，2) 在随机试验中结果令人失望，3) 在大多数情况下导致骨骼损伤 CPR Therapeutics 的一系列试点研究表明，4) 与手动心肺复苏相比没有任何益处。 心输出量和静脉回流增强技术的组合可能会提供附加甚至甚至 正如预期的那样，公司的多功能系统基于 多个心肺复苏泵机制结合除颤和无脉搏同步的概念 电活动（PEA）CPR，将协同血流动力学和电生理学。 在这个直接进入第二阶段的项目中，CPR Therapeutics 应该会显着改善现实世界的临床结果。 将： 1) 设计和建造第三代猪试验台，能够对动物进行高保真毫秒控制 多模式 CPR 泵机制，2) 优化猪的系统配置和组件设计 心室颤动模型，以及 3) 在设计控制和设计控制下设计并构建人体临床原型 该设备将在质量管理体系 (QMS) 中接受结构和功能台架测试。 预计 FDA IDE 的申请除了技术的开发之外，该项目的范围 - 这项工作将显着增加我们关于心肺复苏泵机制之间相互作用的基础科学知识 以及患者组件同步。