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临床试验/NCT05391256
NCT05391256已完成不适用

Referral of Callers to Retrieve Drone-delivered AEDs in Out-of-hospital Cardiac Arrest

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Proportion (percent) of cases where a bystander attaches a drone-delivered AED to the OHCA- patients chest, prior the arrival of EMS.

研究概览

简要总结

Time to defibrillation is the most important predictor of survival in cardiac arrest. Recent studies have shown that unmanned drones can deliver AEDs to the site of real life out-of hospital cardiac arrest (OHCA) before ambulance arrival. Although an AED is available in the close vicinity, they are seldom used. The overall aim of this study is to provide an interventional bundle directed towards the dispatch centre and evaluate referral of callers to retrieve drone-delivered AEDs so that they may be attached in cases out-of-hospital cardiac arrest.

详细描述

This is an observational, non-randomized single group assignment study with the primary purpose of evaluating Referral of callers to retrieve drone-delivered AEDs in out-of-hospital cardiac arrest.

Totally, six AED-equipped drones will be placed in hangars at six different sites covering a geographic area of about 230 km2 and approximately 150,000 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 150 alerts and 60 participants during a study period of up to 12 months. The investigators will closely follow and study the potential of dispatcher referral of 112-callers to retrieve and use drone delivered AEDs prior ambulance arrival.

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 from 30 meters altitude. 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 previous study (version 1.0) a number of hardware and software improvements have been made to the system (version 2.0).

Six hangars are setup at optimal locations in each of the six 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

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 (percent) of cases where a bystander attaches a drone-delivered AED to the OHCA- patients chest, prior the arrival of EMS.

时间窗: Up to 12 months

In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, all cases were a bystander attaches the drone delivered AED to the OHCA-patients chest as instructed in T-CPR protocol before ambulance arrival will be measured. In all alerts to suspected OHCA where a drone took off and delivered an AED on the ground, all cases were a bystander attaches the drone delivered AED to the OHCA-patients chest as instructed in T-CPR protocol before ambulance arrival will be measured. Percentages.

次要结局

  • Proportion (percent) of cases where a dispatcher verbally refers a bystander to retrieve a drone-delivered AED on the ground before EMS arrival in cases of OHCA(Up to 12 months)
  • Proportion (percent) of cases where a bystander successfully retrieves a drone-delivered AED from the ground as instructed by the dispatcher.(Up to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Claesson

Associate Professor

Karolinska Institutet

研究点 (2)

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