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动作同步的外部胸部按压，并将导致更高的全身血流灌注压和接受心肺复苏的PEA心脏骤停患者的改善结果。CST利用ECG信号的数字信号处理技术来控制自动心肺复苏按压装置，并在剩余中心压脉冲的10毫秒内实现胸部按压同步，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了同步压缩可使冠状动脉灌注压（CPP）增加110%，并且表明即使是正确的同步压缩，如果在非同步压缩后进行，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，用于临床前动物研究中控制胸外按压的时间。CST将为自动CPR生命支持压缩装置提供准确的触发信号，使压缩与主动脉压力脉冲精确同步。二期开发包括一种利用心电图数据预测主动脉脉冲到达时间的新方法和反馈控制机制，使CST能够与院前紧急医疗服务人员使用的自动压缩装置和AED集成。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可以调节主动脉脉冲到达时间的生理差异；演示来自外部多普勒超声传感器和加速度计的反馈信号可以改善压缩时序；将CST与商用自动CPR复苏装置集成；同步压迫时冠脉灌注压和脑灌注压升高；并证明与目前标准临床实践的非同步CPR相比，CST按压改善了自发循环的恢复和短期生存能力。在第二阶段的开发中，将设计、建造和测试一个CST原型。我们将了解这项新技术的有效性，以及如何将其整合到现有的复苏设备中。公共卫生叙述：仅在美国，每年就有大约34万人死于心源性猝死，据估计，治疗失败和丧失生产寿命的费用每年超过4000亿美元。虽然其他医学领域的死亡率显著降低，但复苏医学的进展甚微，其中使用心肺复苏术成功复苏心脏骤停患者的比率相当低，特别是对于无脉电活动（PEA）心脏骤停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冲同步。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.