Cardiac Synchronization Technology: Resuscitation Therapy - Pulseless Cardiac Arr

描述（由申请人提供）：心脏同步技术（CST）将提供与无脉电活动（PEA）心脏骤停中存在的微弱残余机械心脏作用同步的胸外按压，并将导致更高的全身血液灌注压，改善接受CPR的PEA心脏骤停患者的结局。CST使用ECG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，为无脉性心脏骤停提供改进的复苏治疗。第一阶段的工作成功地证明，同步压缩提供高达110%的冠状动脉灌注压（CPP）的增加，并指出，即使是正确的同步压缩导致46%的CPP降低，如果在异相压缩后。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外按压的时间。CST将向自动CPR生命支持按压装置提供准确的触发信号，使得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新的方法，使用心电图数据来预测主动脉脉搏到达时间和反馈控制机制，使CST与自动压缩设备和AED的集成，供院前急救医疗服务人员使用。该项目的具体目标是：证明CST可以将心脏按压与实时ECG数据同步，精度为5毫秒;证明CST可以调整主动脉脉冲到达时间的生理差异;证明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与商业自动CPR复苏设备集成;证明同步按压的冠状动脉灌注压和脑灌注压增加;并且证明与当前标准临床实践异步CPR相比，CST按压的自发循环恢复和短期存活率改善。在第二阶段开发中，将设计、建造和测试CST原型。将获得有关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。公共卫生叙述：仅在美国，每年约有340，000人死于心脏性猝死，估计治疗失败和丧失生产性生命年的成本超过每年4000亿美元。虽然其他医学领域已经经历了死亡率的显著降低，但是在复苏医学方面几乎没有取得进展，其中使用CPR对心脏骤停患者进行成功复苏的比率非常低，并且特别地，对于无脉电活动（PEA）心脏骤停的患者没有真正有效的复苏方法。心脏同步技术（CST）旨在提高PEA患者的生存率，使用先进的电路、信号处理和算法将自动生命支持设备与剩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，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.