Drone-Delivered Naloxone System for Opioid Overdose Treatment

项目负责人/主要研究者（最后，第一，中间）：Ornato，Joseph，Pasquale 总结 每天有130名美国人死于阿片类药物过量（OD）。提高存活率的关键是 及时提供解毒剂纳洛酮美国紧急医疗服务（EMS）系统 通常无法以足够快的速度提供救命药物来挽救受害者的生命。我们的专业资格 团队（弗吉尼亚UAS，LLC商业无人机飞行员培训讲师;弗吉尼亚联邦大学 (VCU)教授医师EMS医疗主任/喷气机和商用无人机飞行员，具有丰富的经验 领先的高影响力，多中心，院前NIH临床试验;和VCU工程师， 无人机硬件和软件的开发和商业化）开发了一种新型无人机原型 连接到里士满的9-1-1调度电脑的系统系统会自动加载一个911 旁观者呼叫者的GPS手机位置到无人机，并将其发射到阿片类药物OD携带的现场， 轻型、可拆卸、正在申请专利的实时音频/视频包（COMMRx），含纳洛酮鼻用 喷雾里士满市只有五架无人机可以确保将纳洛酮包裹运送给旁观者 当急救人员开始赶往现场时，训练有素的9-1-1飞行员调度员将直接 旁观者从无人机上取下COMMRx，把它带到受害者那里，并长期使用纳洛酮喷雾剂 在急救人员到达受害者身边之前第一阶段项目建议：1）完成 系统定制; 2）培训/FAA认证的7名9-1-1调度员无人机飞行员; 3）执行逼真的 对系统进行模拟测试，以指导在里士满进行的II期临床试验的设计， 亨利科/切斯特菲尔德县和弗吉尼亚州的罗阿诺克。这一新颖的系统是由一个独特的 一个合格的团队通过授权和指导改变了院前急救护理的模式 外行人在EMS人员之前很久就开始对阿片类药物OD受害者进行时间依赖性，挽救生命的治疗 可以对病人进行物理治疗。我们的商业目标是扩大我们的飞行学校业务， 全国5,783个9-1-1中心的类似能力。 OMB编号0925-0001/0002（2018年1月批准至2020年3月31日修订版）页码续页格式页码

Program Director/Principal Investigator (Last, First, Middle): Ornato, Joseph, Pasquale Summary 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 victim’s 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 Richmond’s 9-1-1 dispatch computer. The system automatically loads a 9-1-1 bystander caller’s 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