Cardiac Synchronization Technology: Resuscitation Therapy - Pulseless Cardiac Arr

描述(由申请人提供)：心脏同步技术(CST)将提供与无脉搏电活动(PEA)心脏骤停时存在的微弱残余机械心脏动作同步的体外胸外按压，并将导致更高的全身血液灌流压并改善接受CPR的PEA心脏骤停患者的预后。CST使用心电信号数字信号处理方面的创新来控制自动CPR按压设备，并使胸部按压在残余中心压脉冲的10毫秒内同步，为无脉搏心脏骤停提供改进的复苏疗法。第一阶段的工作成功地证明，同步按压可使冠脉灌注压(CPP)增加高达110%，并表明即使是正确的同步按压，如果在非相位按压后进行，CPP也会降低46%。第二阶段的工作将在CST原型设备中开发下一代数字电路和算法，用于在临床前动物研究中控制胸部按压的时间。CST将为自动CPR生命支持按压设备提供准确的触发信号，使按压与主动脉压力脉冲精确同步。第二阶段的开发包括一种使用心电数据预测主动脉脉搏到达时间的新方法和反馈控制机制，使CST能够与自动加压设备和AED集成，供院前紧急医疗服务人员使用。该项目的具体目标是展示CST可以以5毫秒的精度将心脏按压与实时心电数据同步；展示CST可以根据主动脉脉搏到达时间的生理差异进行调整；展示来自外部多普勒超声传感器和加速计的反馈信号可以改善按压时间；将CST与商用自动CPR复苏设备集成；展示同步按压的冠状动脉灌注压和脑灌注压增加；以及与当前标准的临床实践异步CPR相比，CST按压改善了自主循环恢复和短期生存能力。在第二阶段的开发中，将设计、建造和测试一台CST原型。将获得关于这项新技术的有效性以及如何将其整合到现有复苏设备中的知识。公共卫生描述：仅在美国，每年就有大约34万人死于心脏性猝死，据估计，失败的治疗和失去的有效寿命每年造成的损失超过4000亿美元。虽然其他医学领域的死亡率显著下降，但在复苏医学方面进展甚微，在使用CPR的心脏骤停患者复苏成功率相当低的情况下，尤其是对于无脉搏电活动(PEA)心脏骤停患者，还没有真正有效的复苏方法。心脏同步技术(CST)旨在提高PEA患者的存活率，使用先进的电路、信号处理和算法将自动生命支持设备与残余心律和主动脉压脉搏同步。特别是对于老龄化的美国人口来说，心脏骤停是一个主要的健康问题和死亡原因，复苏技术的改进可能会带来巨大的社会、经济和个人利益。

DESCRIPTION (provided by applicant): Cardiac Synchronization Technology (CST) will provide external chest compressions synchronized with the weak residual mechanical heart action present in Pulseless Electrical Activity (PEA) cardiac arrest, and will result in higher systemic blood perfusion pressures and improved outcomes for PEA cardiac arrest patients receiving CPR. CST uses innovations in digital signal processing of ECG signals to control automated CPR compression devices and enable chest compressions synchronized within 10 milliseconds of the residual central pressure pulse, providing an improved resuscitation therapy for pulseless cardiac arrest. Phase I work successfully demonstrated that synchronized compressions provide up to 110% increase in coronary perfusion pressure (CPP), and indicated that even correctly synced compressions resulted in 46% lower CPP if given after out-of-phase compressions. Phase II work will develop next generation digital circuitry and algorithms in a CST prototype device for controlling the timing of chest compressions in a pre-clinical animal study. CST will provide an accurate trigger signal to automated CPR life support compression devices, such that the compressions are precisely synchronized to the aortic pressure pulse. Phase II development includes a novel method of using ECG data to predict the aortic pulse arrival time and feedback control mechanisms that enable CST to be integrated with automated compression devices and AED's for use by pre-hospital Emergency Medical Service personnel. Specific goals of this project are to demonstrate CST can synchronize cardiac compressions to real-time ECG data with five millisecond accuracy; demonstrate CST can adjust for physiological differences in the aortic pulse arrival time; demonstrate feedback signals from external Doppler ultrasound sensors and accelerometers can improve compression timing; integrate CST with a commercial automated CPR resuscitation device; demonstrate increased coronary perfusion pressure and cerebral perfusion pressure of synchronized compressions; and demonstrate improved Return Of Spontaneous Circulation and short term survivability with CST compressions versus current standard clinical practice asynchronous CPR. In Phase II development, a CST prototype will be designed, built and tested. Knowledge will be obtained of the effectiveness of this new technology and how to integrate it into existing resuscitation devices. PUBLIC HEALTH NARRATIVE: Each year approximately 340,000 people die from sudden cardiac death in the United States alone, with estimates of costs for failed treatment and lost productive years of life over $400 billion per year. While other areas of medicine have experienced significant reductions in mortality, little progress has been made in resuscitation medicine where the rate for successful resuscitation of cardiac arrest patients using CPR is quite low, and in particular, there are no truly effective resuscitation methods for patients with pulseless electrical activity (PEA) cardiac arrest. Cardiac Synchronization Technology (CST) aims to increase survival rates for patients experiencing PEA, using advanced circuitry, signal processing and algorithms to synchronize automated life support devices to the residual heart rhythm and aortic pressure pulse. Especially for the aging U.S. population, where cardiac arrest is a major health issue and cause of death, improvements in resuscitation techniques could have tremendous societal, economic and personal benefits.