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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06229418
Acronym
RESTORe-CARE
Enrollment
128
Registered
2024-01-29
Start date
2025-09-08
Completion date
2027-03-31
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Sudden Cardiac Arrest

Keywords

Drone, Automated External Defibrillator

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. Sub aim 1b: Develop an optimization model to examine the effectiveness of different options for placement of both public and drone-delivered AEDs in rural communities. This will be done by using CARES Registry data from OHCAs between 2012-2022 from participating EMS agencies in North Carolina. Aim 2: Develop procedural and operational infrastructure for drone AED delivery that can be applied to rural communities. The primary objective of this aim will be to demonstrate that drone AED delivery can be integrated effectively into existing FAA-approved drone-as-first responder programs. Aim 3: Pilot test the safety and effectiveness of emergency drone AED delivery models in 2 urban and 4 rural communities in Forsyth County, NC and James City County, VA. Sub aim 3a: Test the ability of the DRF-AED program to travel to the location of suspected OHCAs and arrive ahead of EMS. There will be 12-15 OHCAs across the 6 communities during this testing period. Sub aim 3b: Test the ability of the DRF-AED program to deliver and safely deploy AEDs (without interrupting bystanders) to sites of suspected OHCA. There will be 10-12 (with a maximum of 15) additional OCHAs across the 6 communities. Sub aim 3c: Test the ability of the DRF-AED program to deliver an AED and treat an OCHA patient suspected cardiac arrests. Up to 70 OHCAs are expected across all 6 communities. Sub aim 3d: Carry out simulated OHCA alerts and test the ability of the DRF-AED program to deliver AEDs to a simulated OCHA scene ahead of EMS or first responders. A minimum of 40 simulations of OHCA (10 per rural community) to occur.

Interventions

OTHERDFR AED Pilot Program

Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs

Sponsors

Duke University
Lead SponsorOTHER
Virginia Commonwealth University
CollaboratorOTHER
University of Toronto
CollaboratorOTHER
University of Washington
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene6 months (Aim 3a)

Secondary

MeasureTime frame
Proportion of OHCA cases with drone arrival ahead of EMS arrival6 months (Aim 3a)
Proportion of times AED was successfully deployed6 months (Aim 3b)
Time from drone arrival on scene to AED delivery on the ground6 months (Aim 3b)
Drone altitude at time of deployment6 months (Aim 3b)
Rates of bystander AED application15 months (Aim 3c)
Proportions of initial shockable rhythm15 months (Aim 3c)
Proportion of bystander defibrillation15 months (Aim 3c)
Proportion of first responder defibrillation15 months (Aim 3c)

Countries

United States

Contacts

CONTACTLeo Brothers, MPH
joseph.l.brothers@duke.edu919-641-3555
CONTACTLauren Wilverding
lauren.wilverding@duke.edu
PRINCIPAL_INVESTIGATORMonique Starks, MD

Duke University

PRINCIPAL_INVESTIGATORDaniel Mark, MD

Duke University

PRINCIPAL_INVESTIGATORJoseph Ornato, MD

Virginia Commonwealth University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026