Transaction Description:
DEVELOPMENT OF A CLOUD-BASED NETWORK OF SMARTWATCH APPLICATIONS TO IMPROVE CARDIOPULMONARY RESUSCITATION DURING CARDIAC ARREST RESPONSE. - PROJECT SUMMARY EACH YEAR, AN ESTIMATED 530,000 ADULTS DIE OF CARDIAC ARREST IN THE USA. MORTALITY RATES ARE EXCESSIVELY HIGH – 90% FOR OUT-OF-HOSPITAL EVENTS AND 75% FOR IN-HOSPITAL EVENTS – AND HAVE REMAINED MOSTLY UNCHANGED FOR OVER A DECADE. WE CAN AND SHOULD DO BETTER. IN THEIR 2020 GUIDELINES, THE AMERICAN HEART ASSOCIATION (AHA) STATES THAT EARLY HIGH-QUALITY CARDIOPULMONARY RESUSCITATION (CPR) IS THE MOST CRITICAL LIFESAVING INTERVENTION FOR A PATIENT IN CARDIAC ARREST. HOWEVER, DELIVERING HIGH-QUALITY CHEST COMPRESSIONS IS DIFFICULT EVEN FOR WELL-TRAINED RESCUERS. HIGH-QUALITY CPR IS BUILT ON ROBUST REGULAR TRAINING AND PERFORMANCE-FOCUSED DEBRIEFING. HOWEVER, MOST RESCUERS STILL TRAIN JUST ONCE EVERY TWO YEARS. THOUGH AHA HAS LAUNCHED INITIATIVES FOR MORE FREQUENT TRAINING, THE CPR AIDS THAT ARE USED IN TRAINING STILL DO NOT ACCOMPANY THE RESCUER DURING CLINICAL RESPONSES. ULTIMATELY, RESCUERS EITHER RELY SOLELY ON THEIR MEMORY, OR USE CURRENT DEFIBRILLATOR-BASED CPR AIDS THAT HAVE QUESTIONABLE BENEFIT IN IMPROVING CPR QUALITY. IN ADDITION, PERFORMANCE DATA REMAINS BURIED IN DEFIBRILLATORS AND ARE NOT ROUTINELY USED FOR PEER QUALITY REVIEWS; THUS, THERE IS NO WAY TO MEASURE IF THE CURRENT TRAINING INITIATIVES ARE IMPROVING CPR QUALITY. THERE IS A NEED FOR HIGHLY FUNCTIONING POINT-OF-CARE TOOLS TO ASSIST PRACTITIONERS DURING A CARDIAC ARREST RESPONSE, AS WELL AS TOOLS THAT ALLOW FOR REGULAR TRAINING IN IN-SITU SETTINGS AND PROVIDE DATA-RICH PERFORMANCE- FOCUSED PEER DEBRIEFING. XIMIO HEALTH, INC. PROPOSES TO DEVELOP THE FIRST SMARTWATCH-ENABLED BASIC LIFE SUPPORT (BLS) APPLICATION FOR USE BOTH IN TRAINING AND CLINICAL RESPONSE. WE WILL DESIGN THE BLS APP WITH REAL-TIME DECISION SUPPORT TO AHA PROTOCOLS AND REAL-TIME CPR DEPTH AND RATE PERFORMANCE FEEDBACK, ENABLING A RESCUER TO BE IMMEDIATELY READY TO PROVIDE HIGH-QUALITY CPR IN AN EMERGENCY. BY LINKING THE BLS APP TO A REAL-TIME CLOUD-BASED NETWORK, WE WILL ENABLE TEAMS TO TRAIN TOGETHER AND RESPOND TO CODES TOGETHER. LASTLY, A CLOUD- BASED SECURE DATABASE WILL ALLOW FOR PEER DEBRIEFING & REVIEWS, MEANING RESCUERS CAN TRACK THEIR PERFORMANCE IMPROVEMENTS. IN PHASE I, WE WILL FIRST DEVELOP A FULLY FUNCTIONAL PROTOTYPE OF THE BLS APP. WE WILL THEN CONDUCT AN IRB-APPROVED FEASIBILITY STUDY USING CPR MANIKINS TO ESTABLISH PROOF-OF-CONCEPT OF THE BLS APP’S PERFORMANCE AND UTILITY AS A CPR AID. THE STUDY WILL ENROLL 30 ADULT PARTICIPANTS ACROSS THREE USER GROUPS: IN- HOSPITAL BLS-CERTIFIED HEALTHCARE PROFESSIONALS, OUT-OF-HOSPITAL BLS-CERTIFIED FIRST RESPONDERS (E.G., EMTS), AND NONCERTIFIED PERSONNEL. UPON SUCCESSFULLY REACHING PROOF-OF-CONCEPT, PHASE II WILL INCLUDE DEVELOPMENT AND DESIGN VERIFICATION TESTING OF THE BLS APP UNDER DESIGN CONTROLS, FOLLOWED BY FDA 510(K) CLEARANCE OF THE BLS APP AND DEVELOPMENT OF SUBSEQUENT APPS AND FUNCTIONALITY TO ACHIEVE OUR PRINCIPAL MISSION OF A CLOUD-BASED NETWORK OF INTERCONNECTED SMARTWATCH APPLICATIONS FOR CARDIAC ARREST QUALITY IMPROVEMENT. OUR OVERARCHING HYPOTHESIS IS THAT RESCUERS AND ORGANIZATIONS WILL IMPROVE THEIR CPR QUALITY, AND ULTIMATELY, SURVIVAL RATES BY IMPLEMENTING A CONTINUOUS QUALITY IMPROVEMENT SYSTEM ENABLED BY OUR INTERACTIVE WEARABLE TECHNOLOGY.
