Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients in the CARES registry who have a traumatic cause of cardiac arrest.
Arms & Interventions
DFR AED Program
Real-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban)
Intervention: DFR AED Pilot Program (Other)
Outcomes
Primary Outcomes
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Time Frame: 15 months (Aim 3c)
Secondary Outcomes
- 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))