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: 10705185
• 负责人: HENRY R HALPERIN
• 金额: $ 108.4万
• 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/10705185
• 关键词: Abdomen; Address; Adhesives; Basic Science; Beds; Blood flow; Brain; Cardiac Output; Cardiopulmonary Resuscitation; Cause of Death; Chest; Circulation; 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; 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; Systems Integration; Techniques; Technology; Testing; Therapeutic; Time; Training; United States; Venous; Ventricular Fibrillation; Ventricular Function; Work; 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; synergism; technological innovation; 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.正在开发第一个用于心肺的多模式自动化系统 复苏（CPR）。该技术将多种泵种机理整合并同步 除颤，并且将是第一个改善心脏骤停患者预后的装置 对商业成功的待遇预测。它将在增强患者和提供者安全的同时这样做。在全国范围内 每年约有65万人遭受心脏骤停。 CPR描述后五十年 存活率通常低于10％，而复苏患者的大部分则具有神经系统 损害。值得注意的是，救援人员执行的护理标准保留手动胸部压缩 他们的手。据估计，与院外心脏骤停有关的社会成本可能就是 美国每年超过330亿美元。毫无疑问，CPR的临床有效改进是 最大的未满足医疗需求。以前所有有效的CPR设备的尝试都具有：1）仅关注一个 一次增强，2）在随机试验中产生令人失望的结果，3）大多数人造成骨骼损伤 患者，以及4）对手册CPR没有任何好处。在一系列试点研究中，CPR疗法证明 心脏输出和静脉返回技术的组合可能会添加甚至可以提供 血液动力学的协同益处。如所设想的，公司的多功能系统基于 多种CPR泵机制，加上除颤和无脉冲的同步的概念 电活动（PEA）CPR将协同血流动力学和电生理学协同作用。这些方法 应该显着改善现实世界的临床结果。在这个直接到相的II项目中，CPR Therapeutics 威尔：1）设计和建造第三代猪试验床，能够高保真毫秒控制 多模式CPR泵送机理，2）优化猪的系统配置和组件设计 心室纤颤的模型，以及3）设计和建造人类的临床原型在设计控制下和 质量管理系统（QMS）。该设备将经过结构和功能性的基准测试 预期提交FDA IDE。除了技术的开发外，该项目的范围 工作将大大增加我们对CPR泵种机理之间相互作用的基础科学知识 和患者组件同步。