Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America (RESTORe-CARE)

May 13, 2026 updated by: Duke University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DFR AED Program
Real-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban)
Other: DFR AED Pilot Program
Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Time Frame: 6 months (Aim 3a)
6 months (Aim 3a)
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Time Frame: 15 months (Aim 3c)
15 months (Aim 3c)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

University of Washington
University of Toronto
Virginia Commonwealth University

Investigators

  • Principal Investigator: Monique Starks, MD, Duke University
  • Principal Investigator: Daniel Mark, MD, Duke University
  • Principal Investigator: Joseph Ornato, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113925
  • 23HERNPRH1150361 (Other Grant/Funding Number: AHA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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