Research Project
7121943
DESCRIPTION (provided by applicant): In the United States, more than 250,000 persons annually experience out-of-hospital sudden cardiac death (SCD). However, few, approximately 4%, are revived with standard CPR and advanced life support interventions and survive to be discharged from the hospital. Successful restoration of cardiac function after SCD is dependent on early electrical defibrillation in patients found to be in ventricular fibrillation (VF) and early provision of effective artificial circulation and ventilation, i.e., CPR. However, standard CPR, as currently practiced, provides only 10-20% of normal cardiac output and low coronary perfusion pressures; and is usually ineffectively performed. A new manual CPR device has been developed and tested in a Phase I STTR. The Phase I study of the LifeBelt(tm) device defined the mechanism of blood flow with the device during cardiac arrest, defined optimal performance parameter for the device, served to stimulate early revisions in the design of the device, and demonstrated efficacy for resuscitation from prolonged cardiac arrest and short-term survival. The specific aims of this Phase II application are a logical extension of the Phase I study: Aim 1: To convert the existing prototype device to a "second generation" pre-production model that replicates the function of the prototype but which is light weight, made of inexpensive material, and easily produced in quantity. This will be accomplished through collaboration with a mechanical/bioengineering team. Aim 2: To compare the second generation device to standard manual CPR, using manikin simulators, for "ease of use" characteristics in different "rescuer" populations. These rescuers will include physicians, nurses, paramedics, and lay persons. Aim 3: To compare long-term (72 hour) neurologic outcome after prolonged cardiac arrest and resuscitation with the LifeBelt(tm) device versus manual CPR in a swine model. The long-term objective of the project is the production of a simple manual CPR device that will produce greater blood flow than standard CPR, minimize the need for mouth-to-mouth ventilation, and that can be used by the lay person with minimal instruction. The device could easily be deployed with existing automatic external defibrillators (AEDs) which provide brief and simple audio instruction regarding use. Use of early and effective CPR with the new device preceding or following early defibrillation attempts by lay persons (public access defibrillation) could result in more lives saved.
