Cooperative Agreement 2136787

STTR PHASE II: DEVELOPMENT OF SAFETY ACCESSORY FOR IMPROVING PERFORMANCE AND MINIMIZING COMPLICATIONS OF MANUAL VENTILATION -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PHASE II PROJECT WILL BE TO REDUCE THE RISK OF COMPLICATIONS AND ASSOCIATED COSTS CAUSED BY STANDARD BAG VALVE MASK (BVM) RESUSCITATORS, WHICH ARE WIDELY USED IN EMERGENCY RESUSCITATION AND AIRWAY MANAGEMENT. IN THE UNITED STATES, ABOUT 13.1 MILLION BVMS ARE USED ANNUALLY. MEDICAL PROVIDERS FREQUENTLY DELIVER UNSAFE MANUAL VENTILATION WITH BVMS, REGARDLESS OF THE QUALIFICATIONS AND EXPERIENCE OF THE PROVIDER. DANGEROUSLY HIGH PRESSURES, FLOW RATES, AND VOLUMES OF AIR FLOW CAN RESULT IN COMPLICATIONS SUCH AS GASTRIC INSUFFLATION, AND LESS FREQUENTLY, ASPIRATION PNEUMONIA, ACUTE LUNG INJURY, ACUTE RESPIRATORY DISTRESS SYNDROME, BAROTRAUMA, VOLUTRAUMA, AND PNEUMOTHORAX. THERE IS AN URGENT NEED FOR AN INTERVENTION TO IMPROVE PATIENT SAFETY DURING MANUAL VENTILATION WITH THE RESUSCITATOR BAG. THIS PROJECT INVOLVES THE DEVELOPMENT OF A SAFETY DEVICE TO BE USED WITH ALL STANDARD BVMS ON THE MARKET TO REGULATE AIR FLOW AND PRESSURE. THE DEVICE THAT WILL OFFER SAFE, AFFORDABLE, AND OPTIMIZED VENTILATION WHILE MINIMIZING GASTRIC INSUFFLATION. THE TECHNOLOGY SHOULD HAVE BROAD APPLICATIONS ACROSS THE ENTIRE CARE CONTINUUM, BUT ESPECIALLY IN EMERGENCY AND BATTLEFIELD MEDICINE. THIS SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PHASE II PROJECT SEEKS TO FURTHER DEVELOP AND OPTIMIZE THE BVM SAFETY. THIS EFFORT OPTIMIZES THE HAPTIC AND AUDITORY FEEDBACK THE PROVIDER RECEIVES WHEN USING THE DEVICE AND OPTIMIZES THE DESIGN AND MANUFACTURABILITY OF THE PRODUCT. IN ADDITION, BIOCOMPATIBILITY STUDIES AND ANIMAL STUDIES OF THE DEVICE IN ANESTHETIZED PIGS AND IN PIGS UNDERGOING CARDIAC ARREST WILL PROVIDE DATA NECESSARY FOR FDA CLEARANCE. THIS PHASE II WORK WILL ENSURE THAT PATIENTS WILL RECEIVE THE MOST OPTIMAL EVIDENCE-BASED TREATMENT AND WILL HELP ESTABLISH THE SAFETY DEVICE AS THE STANDARD OF CARE. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.