The goal of this SBIR Phase II application is to continue the development and evaluation of a novel device designed to increase the efficiency of manual CPR. This hand-held lightweight device, termed the ErgoPad, helps to transform the thorax into a bellows during CPR, thereby enabling the rescuer to manually perform active compression decompression (ACD) CPR. The combination of ACD CPR and the inspiratory impedance threshold device (ITD) quadruples blood flow to the heart and brain compared with manual CPR alone. The ITD was invented by the applicant and recently commercialized. The ErgoPad and ITD technologies work synergistically to decrease the decompression phase intrathoracic pressure, creating a vacuum within the thorax relative to the rest of the body, thereby a) enhancing blood return to the thorax, b) enhancing blood return to the brain, c) providing real-time feedback to rescuers to maintain high quality CPR, and d) improving overall CPR efficiency. The ErgoPad is intended for home and professional rescuer use to increase the chances for meaningful survival after cardiac arrest. The ErgoPad has been shown in Phase I studies to be significantly better than the current suction cup version of the ACD CPR device as it is lighter in weight, adheres better to the chest, allows the rescuer's hands to be closer to the chest, does not wobble and thereby transfers kinetic energy more efficiently, is easier to use, has a more user-friendly gauge to guide compressions and decompressions, requires less work, has a larger compression surface to optimize dispersion of compression forces, is easier to store in a small box with a defibrillator, and is more amenable to adapt to a skin electrode for physiological monitoring or defibrillation. Phase I proof of concept studies also demonstrated that the combination of the ErgoPad and ITD increased neurologically intact survival in a well established porcine model of cardiac arrest, in which we extended arrest without CPR time to 8.5 minutes and resuscitated >90% of the animals. The SBIR Phase II research is primarily intended to further develop the ErgoPad and ITD combination by a) adding several key features including audio and visual cues to guide rescuers on the optimal performance of CPR so that it can be easily implemented into the home and ambulance setting, b) creating and evaluating an easy to understand training program for the lay rescuer, and c) measuring the clinical performance of the ErgoPad in patients in cardiac arrest. Once Phase II studies are completed, the ErgoPad and ITD will be ready for commercialization into the home and professional markets. This SBIR Phase 2 research is primarily intended to further develop a manual active compression decompression cardiopulmonary resuscitation (ACD CPR) device that can be easily used by lay and professional rescuers so that it can be implemented into the home and ambulance setting, to create and evaluate an easy to understand training program for the lay rescuer, and to measure device performance in patients in cardiac arrest. If this program is successful, the new resuscitation system has the potential to resuscitate approximately 50,000 more patients of the 400,000 sudden cardiac deaths that occur outside the hospital each year in the United States. This estimation does not take into account a nearly equal number of patients with sudden cardiac death that occur in-hospital each year. With the increasing trend of vital life saving technologies such as external defibrillators being bought for home use, this new resuscitation system is an ideal technology for the lay rescuer to use at home. ? ? ?
