One hundred thirty Americans die from an opioid overdose (OD) daily. The key to improving this survival is the timely delivery of the antidote naloxone. Current US Emergency Medical Services (EMS) systems are often unable to deliver the life-saving drug fast enough manner to save the victims life. Our uniquely-qualified team (Virginia UAS, LLC commercial drone pilot training instructors; a Virginia Commonwealth University (VCU) faculty physician EMS medical director/jet and commercial drone pilot with extensive experience leading high-impact, multicenter, prehospital NIH clinical trials; and VCU engineers with experience in development and commercialization of drone hardware and software) has developed a novel prototype drone system that is interfaced to Richmonds 9-1-1 dispatch computer. The system automatically loads a 9-1-1 bystander callers GPS phone location into a drone and launches it to the scene of an opioid OD carrying a lightweight, removable, patent-pending, real-time audio/video package (COMMRx) containing naloxone nasal spray. Just five drones in the City of Richmond could ensure delivery of the naloxone package to bystanders in ?2 min as EMS first responders begin racing to the scene. Trained 9-1-1 pilot dispatchers would direct the bystander to remove COMMRx from the drone, take it to the victim, and administer the naloxone spray long before first responders can physically reach the victim. This Phase I project proposes to: 1) finalize the system customization; 2) train/FAA-certify seven 9-1-1 dispatchers drone pilots; and 3) perform realistic simulation testing of the system to guide design of a Phase II clinical trial to take place in Richmond, Henrico/Chesterfield counties, and Roanoke, VA. This novel system developed and executed by a uniquely qualified team shifts the paradigm of prehospital emergency care delivery by empowering and directing laypersons to initiate time-dependent, life-saving treatment to opioid OD victims long before EMS personnel can physically treat the patient. Our commercial goal is to expand our flight school business to provide similar capability throughout the 5,783 9-1-1 centers nationally. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page
Public Health Relevance Statement: Program Director/Principal Investigator (Last, First, Middle): Ornato, Joseph, Pasquale Emergency Medical Services (EMS) systems cant reliably deliver life-saving naloxone antidote treatment needed to save opioid overdose (OD) victims because first responders cant physically get there in time. We propose to finalize development of our novel, rapid, drone delivery system that can deliver naloxone spray antidote and direct lay bystanders to administer the life-saving treatment. Our proposal can be implemented cost-effectively at 9-1-1 centers nationwide to mitigate the mortality burden from the ongoing opioid crisis. OMB No. 0925-0001/0002 (Rev. 01/18 Approved Through 03/31/2020) Page Continuation Format Page
Project Terms: Aircraft; Ambulances; American; Antidotes; authority; Breathing; Businesses; care delivery; Certification; Cessation of life; Charge; Cities; Clinical Trials; college; commercialization; Communication; Computer software; Computers; cost; cost effectiveness; County; Custom; Data; design; Destinations; Development; Emergency Care; Emergency Department Physician; Emergency medical service; empowered; Engineering; Ensure; Environment; experience; Faculty; first responder; Funding; Goals; Heart; Human Resources; improved; instructor; instrument; Legal patent; Licensure; Life; light weight; Location; Manikins; Medical; mortality; Multi-Institutional Clinical Trial; Naloxone; Nose; novel; opioid epidemic; opioid overdose; Paramedical Personnel; Patients; Pharmaceutical Preparations; Phase; Phase II Clinical Trials; Physician Executives; Prehospital Emergency Care; Principal Investigator; Process; programs; prototype; Provider; Race; Rural; rural area; Savings; Schools; Services; simulation; suburb; System; Teacher Professional Development; Telephone; Testing; Time; Training; United States National Institutes of Health; Universities; Veterans; Virginia; Visual
