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临床试验/NCT06229418
NCT06229418招募中不适用

Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America

Duke University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene

研究概览

简要总结

The overall goal of this project is to design, develop, and pilot test an emergency healthcare drone delivery system suitable for rural communities that can deliver AEDs to out-of-hospital cardiac arrest (OHCA) locations more rapidly than can be achieved with current first responder and EMS systems. The goal is to determine whether this method of AED delivery can be achieved rapidly enough to justify a future clinical trial directly testing its ability to improve OHCA survival.

详细描述

To achieve the project goal, 3 specific aims will be addressed. The details in this ClinicalTrials.gov record are specific to Aim 3.

Aim 1:

Define options for emergency healthcare drone station configurations best suited for rural communities and use these findings to help design future drone AED delivery programs in rural communities.

Sub aim 1a:

Define and examine EMS agency treatment, performance, and outcomes of OCHA in rural versus urban regions across the US. This will be done by using CARES Registry data from all OHCA treated by emergency medical professionals from participating EMS agencies in the US between 2021-2022.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years of age or older in the CARES registry who suffer cardiac arrest before arrival of a 911-responder of non-traumatic cause, including patients who receive an AED shock by a bystander prior to the arrival of 911 responders.

排除标准

  • Patients in the CARES registry who have a traumatic cause of cardiac arrest.

研究组 & 干预措施

DFR AED Program

Experimental

Real-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban)

干预措施: DFR AED Pilot Program (Other)

结局指标

主要结局

Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene

时间窗: 15 months (Aim 3c)

次要结局

  • Drone altitude at time of deployment(6 months (Aim 3b))
  • Proportions of initial shockable rhythm(15 months (Aim 3c))
  • Time from drone arrival on scene to AED delivery on the ground(6 months (Aim 3b))
  • Proportion of times AED was successfully deployed(6 months (Aim 3b))
  • Proportion of bystander defibrillation(15 months (Aim 3c))
  • Proportion of first responder defibrillation(15 months (Aim 3c))
  • Proportion of OHCA cases with drone arrival ahead of EMS arrival(15 months (Aim 3c))
  • Rates of bystander AED application(15 months (Aim 3c))

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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