Cedc Incorporated

PHASE II, HEAD UP CARDIOPULMONARY RESUSCITATION DEVICE - ABSTRACT SUDDEN CARDIAC ARREST (SCA) IS A LEADING CAUSE OF DEATH IN THE USA, WITH ONLY 3-20% NEUROLOGICALLY INTACT SURVIVAL FOR >350,000 OUT-OF-HOSPITAL SCA PATIENTS EACH YEAR. EVEN AFTER PATIENTS ARE INITIALLY RESUSCITATED, MANY DIE WITHIN A WEEK FROM SEVERE BRAIN INJURY. THE GOAL OF THIS APPLICATION IS TO IMPROVE NEUROLOGICALLY-INTACT SURVIVAL RATES AFTER PRE-HOSPITAL AND IN-HOSPITAL SCA. THE PHASE I PRE-CLINICAL STUDIES SHOWED 1) ELEVATION OF THE HEAD AND THORAX DURING ACTIVE COMPRESSION DECOMPRESSION (ACD) CPR WITH AN IMPEDANCE THRESHOLD DEVICE (ITD) DOUBLED BRAIN BLOOD FLOW VERSUS ACD+ITD CPR IN THE FLAT POSITION AND, 2) CONTROLLED AND SEQUENTIAL HEAD AND THORAX ELEVATION WITH ACD+ITD CPR RESULTED IN A 6-FOLD INCREASE IN NEUROLOGICALLY-INTACT SURVIVAL VERSUS CONVENTIONAL CPR IN THE FLAT POSITION. THIS NOVEL METHOD OF CPR IS CALLED HEAD UP POSITION (HUP) CPR. IT WORKS BY HARNESSING GRAVITY TO ENHANCE VENOUS BLOOD FLOW FROM THE BRAIN TO THE HEART, LOWER INTRACRANIAL PRESSURE, AND ENHANCE CARDIAC OUTPUT. THE FIRST HUMAN HUP CPR DEVICE, THE ELEGARDTM, WAS DESIGNED, BUILT, AND TESTED WITH PHASE I FUNDING SUPPORT. THE ELEGARD SUBSEQUENTLY RECEIVED FDA 510K CLEARANCE AND HAS BEEN USED TO HELP TREAT >400 SCA PATIENTS TO DATE. BASED UPON THESE POSITIVE OUTCOMES, THE PHASE II OBJECTIVES ARE TO 1) DESIGN, DEVELOP, AND BUILD AN IMPROVED ELEGARD-2 TO ACCELERATE TIME TO DEVICE APPLICATION AND INCREASE ADOPTION RATES THROUGH A) A REDUCTION IN SIZE AND WEIGHT AND AN IMPROVED USER INTERFACE, B) ADDITION OF REGIONAL CEREBRAL OXIMETRY (RSO2) AND, C) INCORPORATION OF AUTOMATED POSITIVE PRESSURE BREATH DELIVERY TO INCREASE CREW SAFETY IN THE AGE OF COVID-19; 2) DEMONSTRATE NEUROLOGICALLY-INTACT SURVIVAL IS SUPERIOR WITH ACD+ITD HUP CPR VERSUS ACD+ITD CPR FLAT IN A PIG MODEL THAT INCLUDES SALVAGE WITH EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) TO EVALUATE THE POTENTIAL BENEFIT OF HUP CPR WITH THE RAPIDLY EVOLVING USE OF ECMO FOR SCA; AND 3) DEMONSTRATE HUP CPR UTILIZING ELEGARD-2 REDUCES BRAIN INJURY IN A PIG MODEL OF SCA UTILIZING ADVANCED IMAGING TECHNIQUES. THE NEXT GENERATION HUP CPR DEVICE WILL BE EASIER TO STORE, CARRY, AND DEPLOY, WILL PROVIDE RSO2 TO BETTER GUIDE CARE, AND PROVIDE AUTOMATED BREATH DELIVERY TO INCREASE CREW SAFETY AND REDUCE THE NUMBER OF RESCUERS NEEDED TO PERFORM CPR. THE ANIMAL STUDIES WILL HELP DETERMINE THE POTENTIAL FOR HUP CPR TO EXTEND PHYSIOLOGIC VIABILITY DURING RESUSCITATION IN REFRACTORY VENTRICULAR FIBRILLATION UNTIL BETTER HEMODYNAMIC SUPPORT IN THE FORM OF ECMO IS AVAILABLE, AND HELP DETERMINE IF HUP CPR REDUCES BRAIN INJURY, AS DETERMINED BY MRI AND MEASUREMENT OF BIOCHEMICAL MARKERS. COLLECTIVELY, PHASE II FUNDING WILL SUPPORT THE DEVELOPMENT OF THE NEXT GENERATION HUP CPR PLATFORM AND ACCELERATE ADOPTION OF THIS INNOVATIVE TECHNOLOGY TO IMPROVE NEUROLOGICALLY-INTACT SURVIVAL RATES AFTER SCA.

HEAD UP CPR SYSTEM WITH INTEGRATED AND OPTIMIZED MECHANICAL ACTIVE COMPRESSION DECOMPRESSION FOR IMPROVING SURVIVAL AFTER CARDIAC ARREST - ABSTRACT THE OVERALL GOAL OF THIS APPLICATION IS TO IMPROVE NEUROLOGICALLY-INTACT SURVIVAL RATES AFTER SUDDEN CARDIAC ARREST (SCA), THE LEADING CAUSE OF DEATH IN ADULTS IN THE US. DESPITE CONVENTIONAL (C) CPR, <10% OF 300,000 PRE- HOSPITAL AND <30% OF 300,000 IN-HOSPITAL SCA PATIENTS IN THE US EACH YEAR SURVIVE WITH FAVORABLE NEUROLOGICAL FUNCTION. WE PROPOSE TO DEVELOP AND EVALUATE A NOVEL COMPREHENSIVE HEAD UP POSITION (HUP) CARDIOPULMONARY RESUSCITATION (CPR) SYSTEM DESIGNED PRIMARILY TO ALLOW BASIC LIFE SERVICES (BLS) PROVIDERS (A FIRE CREW WITHOUT PARAMEDICS) TO RAPIDLY DELIVER FULLY AUTOMATED CPR, INCLUDING FOR THE FIRST TIME, AUTOMATED BREATH DELIVERY AND AUTOMATED AND OPTIMIZED FULL LIFT ACTIVE COMPRESSION DECOMPRESSION, TO INCREASE THE LIKELIHOOD OF NEUROLOGICALLY INTACT SURVIVAL AFTER SCA AND INCREASE CREW SAFETY. THE PROPOSAL FOCUSES ON FURTHER DEVELOPING AND DELIVERING AN INNOVATIVE ALL-IN-ONE HUP RESUSCITATION SYSTEM (HRS) FOR BLS TEAMS BASED ON OUR MOST RECENT BREAKTHROUGHS IN OPTIMIZING BRAIN PERFUSION DURING SCA USING CONTROLLED SEQUENTIAL ELEVATION OF THE HEAD AND THORAX COMBINED WITH ACTIVE COMPRESSION DECOMPRESSION (ACD) CPR AND AN IMPEDANCE THRESHOLD DEVICE (ITD). AS DEMONSTRATED IN A WELL-ACCEPTED PORCINE SCA MODEL, HUP CPR COMBINED WITH FULL LIFT ACD CPR AND AN ITD UNIQUELY HARNESSES GRAVITY TO ENHANCE DRAINAGE OF VENOUS BLOOD FROM THE HEAD AND NECK, LOWER INTRACRANIAL PRESSURE, AND MARKEDLY INCREASE SYSTEMIC AND CEREBRAL BLOOD FLOW AND LIKELIHOOD FOR NEUROLOGICALLY-INTACT SURVIVAL. THE OVERALL OBJECTIVES OF THIS APPLICATION ARE ALSO SUPPORTED BY NEW CLINICAL DATA FROM A HUP CPR REGISTRY DEMONSTRATING THIS NEUROPROTECTIVE APPROACH PROVIDES A STRIKING BENEFIT WHEN DEPLOYED RAPIDLY BY EMERGENCY MEDICAL SERVICES (EMS) FIRST RESPONDERS. MOREOVER, IN RESOURCE-STRAPPED EMS SYSTEMS COUNTRYWIDE THERE IS A GROWING NEED TO DEVELOP TECHNOLOGY THAT MINIMIZES THE NUMBER OF RESOURCES REQUIRED TO DELIVER HIGH QUALITY CPR THAT IS BEST FOR PATIENT OUTCOMES AND SAFER FOR RESCUE PERSONNEL. WE PROPOSE TO ACHIEVE THESE COLLECTIVE OBJECTIVES BY DEMONSTRATING THAT INCORPORATION OF 1) AUTOMATED AND INTEGRATED ACD CPR AND 2) AUTOMATED BREATH DELIVERY INTO AN EASY TO DEPLOY AND FULLY AUTOMATED HUP CPR SYSTEM, IS FEASIBLE AND SAFE FOR BLS PROVIDERS, WILL REDUCE CPR PERSONNEL RESOURCE REQUIREMENTS, AND MOST IMPORTANTLY, WILL OPTIMIZE CHANCES FOR NEUROLOGICALLY INTACT SURVIVAL AFTER SCA. AS SUCH, THE SPECIFIC AIMS ARE: 1) DETERMINE THE OPTIMAL WAVEFORM DURING HUP WITH FULL ACD CPR TO OPTIMIZE BRAIN AND HEART BLOOD FLOW AND COMPARE THE OPTIMIZED WAVEFORM WITH A LUCAS 3.1 WAVEFORM IN A PORCINE SURVIVAL STUDY AND 2) DESIGN AND PROTOTYPE A FUNCTIONAL HRS, AN ALL-IN-ONE DEVICE WITH INTEGRATED, OPTIMIZED, AND AUTOMATED FULL ACD CPR AND AUTOMATED BREATH DELIVERY.

FULLY AUTOMATED BASIC LIFE SERVICES RESUSCITATION SYSTEM TO IMPROVE SURVIVAL AFTER CARDIAC ARREST - ABSTRACT THE OVERALL GOAL OF THIS APPLICATION IS TO IMPROVE NEUROLOGICALLY-INTACT SURVIVAL RATES AFTER SUDDEN CARDIAC ARREST (SCA). STILL A LEADING CAUSE OF DEATH, <10% OF THE MORE THAN 600,000 SCA PATIENTS IN THE US EACH YEAR SURVIVE WITH FAVORABLE NEUROLOGICAL FUNCTION. WE PROPOSE TO DEVELOP AND EVALUATE A NOVEL COMPREHENSIVE HEAD UP (HUP) CARDIOPULMONARY RESUSCITATION (CPR) SYSTEM DESIGNED PRIMARILY TO ALLOW BASIC LIFE SERVICES (BLS) PROVIDERS (A FIRE CREW WITHOUT PARAMEDICS) TO RAPIDLY DELIVER FULLY AUTOMATED CPR, INCLUDING FOR THE FIRST TIME, AUTOMATED SYNCHRONIZED MECHANICAL POSITIVE PRESSURE VENTILATION (PPV), TO INCREASE THE LIKELIHOOD OF NEUROLOGICALLY INTACT SURVIVAL AFTER SCA AND INCREASE CREW SAFETY. THE PROPOSAL FOCUSES ON FURTHER DEVELOPING AND DELIVERING AN INNOVATIVE ALL-IN-ONE DEVICE FOR BLS TEAMS BASED ON OUR MOST RECENT BREAKTHROUGHS IN OPTIMIZING BRAIN PERFUSION DURING SCA USING CONTROLLED SEQUENTIAL ELEVATION OF THE HEAD AND THORAX IN COMBINATION WITH THE USE OF ACTIVE COMPRESSION DECOMPRESSION (ACD) CPR AND AN IMPEDANCE THRESHOLD DEVICE (ITD). AS DEMONSTRATED IN A WELL-ACCEPTED PORCINE SCA MODEL, HUP CPR COMBINED WITH ACD CPR AND AN ITD UNIQUELY HARNESSES GRAVITY TO ENHANCE DRAINAGE OF VENOUS BLOOD FROM THE HEAD AND NECK, LOWER INTRACRANIAL PRESSURE, AND MARKEDLY INCREASE SYSTEMIC AND CEREBRAL BLOOD FLOW AND LIKELIHOOD FOR SURVIVAL. THE OVERALL OBJECTIVES OF THIS APPLICATION ARE ALSO SUPPORTED BY NEW CLINICAL DATA FROM A CPR REGISTRY OF PATIENTS RECEIVING HUP CPR SUGGESTING THIS COMPREHENSIVE APPROACH MAY PROVIDE THE MOST BENEFIT WHEN DEPLOYED RAPIDLY. MOREOVER, IN RESOURCE-STRAPPED EMERGENCY MEDICAL SERVICES (EMS) SYSTEMS ACROSS THE COUNTRY THERE IS A GROWING NEED TO DEVELOP TECHNOLOGY THAT MINIMIZES THE NUMBER OF RESOURCES REQUIRED TO DELIVER HIGH QUALITY CPR THAT IS BEST FOR PATIENT OUTCOMES AND SAFER FOR RESCUE PERSONNEL. WE PROPOSE TO ACHIEVE THESE COLLECTIVE OBJECTIVES BY DEMONSTRATING THAT INCORPORATION OF AUTOMATED POSITIVE PRESSURE VENTILATION (PPV), SYNCHRONIZED TO THE DECOMPRESSION PHASE OF AN EASY TO DEPLOY AND FULLY AUTOMATED HUP CPR SYSTEM, IS FEASIBLE AND SAFE FOR BLS PROVIDERS, WILL REDUCE CPR PERSONNEL RESOURCE REQUIREMENTS, AND MOST IMPORTANTLY, WILL OPTIMIZE CHANCES FOR NEUROLOGICALLY INTACT SURVIVAL AFTER SCA. THIS COMBINATION OF INNOVATIONS, DESCRIBED HEREIN AS THE SAVE CPR SYSTEM, REPRESENTS THE COMBINATION OF SYNCHRONIZATION, ACD+ITD, VENTILATION, AND ELEVATION. AS SUCH, THE SPECIFIC AIMS ARE: 1) DESIGN AND PROTOTYPE AN IMPROVED HEAD UP CPR DEVICE WHICH INCLUDES AUTOMATED PPV THAT IS SYNCHRONIZED WITH THE DECOMPRESSION PHASE OF ACD CPR; 2) DETERMINE IF THE SAVE CPR SYSTEM WILL INCREASE 24-HOUR SURVIVAL WITH FAVORABLE BRAIN FUNCTION WHEN IMPLEMENTED IMMEDIATELY AFTER 10 MINUTES OF UNTREATED CARDIAC ARREST COMPARED WITH A DELAYED IMPLEMENTATION STRATEGY WHEREBY SAVE IS INITIATED AFTER 10 MINUTES OF UNTREATED CARDIAC ARREST AND 8 MINUTES OF CONVENTIONAL CPR TO SIMULATE ADVANCED LIFE SUPPORT (ALS) RATHER THAN BLS DEPLOYMENT OF THE SAVE CPR SYSTEM; AND 3) TEST THE FEASIBILITY OF USE OF THE SAVE CPR SYSTEM BY BLS PROVIDERS IN SIMULATED CARDIAC ARREST SCENARIOS USING MANIKINS AND HUMAN CADAVERS TO DETERMINE IF RESCUERS CAN RAPIDLY DEPLOY AND UTILIZE THE SAVE SYSTEM AND TO EVALUATE WHAT POTENTIAL IMPROVEMENTS ARE NECESSARY FOR A COMMERCIALLY VIABLE VERSION. WE ANTICIPATE BEING ABLE TO DEMONSTRATE A) THE ABILITY TO INCORPORATE A PPV DELIVERY DEVICE INTO THE SAVE CPR SYSTEM B) PRE-CLINICAL PROOF-OF-CONCEPT THAT THE SAVE CPR SYSTEM WILL SIGNIFICANTLY IMPROVE NEUROLOGICALLY-SOUND SURVIVAL IN PIGS WHEN DEPLOYED RAPIDLY VERSUS DEPLOYING THE SAVE CPR SYSTEM AFTER A PERIOD OF TRADITIONAL CONVENTIONAL CPR, AND C) THAT THE SAVE CPR CAN BE EASILY AND RAPIDLY APPLIED BY BLS PROVIDERS.

HEAD UP CARDIOPULMONARY RESUSCITATION DEVICE

RBDG RURAL BUSINESS COOP RURAL ENTERPRISE GRANT