Despite the widespread practice of basic and advanced life support, over 1000 patients die each day in the United States from an out-of-hospital cardiac arrest. Even though they receive standard cardiopulmonary resuscitation (sCPR) the average national survival to hospital discharge for these patients remains <5%. The applicants have developed two new CPR devices, the inspiratory impedance threshold device (ITD) and an active compression decompression (ACD) CPR device that together quadruple blood flow to the heart and brain when used in combination and compared with sCPR. The ITD is the size of a child's fist and it is attached to the airway via a face mask or breathing tube. The ACD CPR is a hand-held device that compresses the chest like a pair of hands but facilitates active and full chest wall recoil as it has a suction cup that attaches to the chest. These devices work synergistically by increasing the extent and duration of negative intrathoracic pressure or intrathoracic vacuum during the chest wall recoil phase of sCPR, thereby more effectively refilling the heart after each chest compression. The Phase 2 clinical trial, which was focused only on the ITD + sCPR, demonstrated that intensive care unit admission rate (primary study endpoint) in patients with an initial heart rhythm of pulseless electrical activity increased from 19% to 52% (p=0.02). The Phase 2 research further lead to the discovery that during sCPR ventilation rates and duration are often excessive and that the chest is often not allowed to fully recoil after each compression. Each of these common clinical errors was electronically recorded for the first time and then shown to be detrimental, if not deadly, in follow-up animal studies on cardiac arrest. Based upon these Phase 2 results the applicants improved the ITD by adding a ventilation timing light to guide proper ventilation and added ACD CPR to the study design to assure that the critically important full chest recoil occurs after each chest. Building upon the Phase 2 results, the Phase 2 Continuation research is being conducted to obtain sufficient clinical data for regulatory clearance for the ITD and ACD CPR as a technology intended to improve hospital discharge and 30 day neurologically-intact survival after cardiac arrest. Funding is being request to complete a pivotal SBIR Phase 2 Continuation study comparing sCPR versus ACD CPR + the ITD designed as a prospective, randomized, 1400 patient, 6-site clinical trial. Hospital discharge with good neurological function is the primary endpoint and survivors will be followed for up to one year. With 400,000 out-of-hospital deaths from cardiac arrest in the United States alone, widespread application of this technology could result in more than 50,000 neurologically-intact survivors per year.
This SBIR Phase 2 Continuation research is primarily intended to obtain sufficient clinical data for regulatory clearance for the combination of an impedance threshold device (ITD, ResQPOD.) and an active compression decompression CPR device (ACD CPR, ResQPump.) as a technology intended to improve 30 day intact neurological survival after cardiac arrest. A pivotal clinical trial is proposed in the form of a prospective, randomized, 1400 patient, six-site clinical trial to determine the 30 day survival rate with intact neurologic function when using the ITD and assuring full chest wall recoil with ACD CPR compared to sCPR alone. 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. ? ? ?
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