AED-delivery Using Drones in Suspected Out-of-hospital Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Proportion (%) of AED-drone arrival prior to ambulance.
研究概览
简要总结
Time to defibrillation is the most important predictor of survival in cardiac arrest. Traditional emergency medical system response is often to slow. The overall aim of this pilot study is to evaluate if drones can deliver Automated external defibrillators (AEDs) to the scene of suspected out-of-hospital cardiac arrest (OHCA) prior to ambulance arrival with clinically relevant time benefits.
详细描述
This is an observational, non-randomized single group assignment study with the primary purpose of evaluating proportion of AED-delivery prior to ambulance arrival and time benefits.
Totally, five AED-equipped drones will be placed in hangars at five different sites covering a geographic area of about 200 km2 and approximately 125,000 inhabitants for dispatch to suspected cases of OHCA as a complement to standard care i.e., ambulance. By coordinating the operations with local Air Traffic Control (ATC), the risk of airspace conflicts, or in worst case collisions, is mitigated to an acceptable level.
The investigators estimate to enroll some 80 alerts and 60 participants during a study period of up to 14 months. The investigators will closely follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance during a period of up to 14 months in which the investigators will follow and study the potential of delivering AEDs prior ambulance arrival and timesaving effects as compared to ambulance.
The drone operator, Everdrone, has integrated all software and hardware for the concept on the DJI Matrice 600 Pro drone. Examples of added features: an integrated Parachute Rescue System (validated by independent third party using the ASTM F3322 - 18 standard), a high precision sense and avoid system and a winching device to safely lower the AED to ground at delivery. Furthermore, Everdrone AB has fully integrated their system and operational routines with the dispatch central, emergency medical services and aviation organizations. As a result from the previous study (version 1.0) a number of hardware and software improvements have been made to the system (version 2.0):
Five hangars will be setup at optimal locations in each of the five administrative areas. Hangars are large isolated tents 4x4 meters in where the drone is placed, remotely operated and surveiled by camera. Hangars are within fenced areas so that the public has no access. They are equipped with weather stations and an automated gate which automatically will open on alert.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All suspected OHCA during 112-calls including drowning
- •Within prespecified administrative areas (excluding no delivery- and no-fly zones)
- •Hours of operation: 08:00-22:00 (daylight conditions)
- •Drone system online
排除标准
- •Children <8 years
- •EMS-witnessed cases
- •Post alert:
- •ATC non-approval of flight
- •Rain, winds exceeding 8m/s (median)
结局指标
主要结局
Proportion (%) of AED-drone arrival prior to ambulance.
时间窗: Up to 14 months
In all alerts of suspected OHCA where a drone took off, comparisons will be done on proportion (%) of AED-drones arriving first on scene vs the proportion (%) of ambulances arriving first on scene. Accurate completion of mission is defined as delivery of an AED onsite on the ground in close connection from the OHCA and drone operator reporting arrival status "F" back to the dispatch centre. AEDs shall be accessible to the bystander through T-CPR instructions given by the dispatcher.
次要结局
- c) Proportion (%) of attached drone delivered AEDs prior the arrival of EMS. Percentages.(Up to 14 months)
- Median time difference (min:sec) between AED-drone and ambulance.(Up to 14 months)
- d) Proportion (%) of cases defibrillated when a drone delivers an AED before ambulance arrival (real OHCA)(Up to 14 months)
研究者
Andreas Claesson
RN, Associate professor
Karolinska Institutet