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

NCT ID: NCT06229418

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-03-31

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.

Conditions

Cardiac Arrest; Sudden Cardiac Arrest

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DFR AED Program

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

Group Type: EXPERIMENTAL

DFR AED Pilot Program

Intervention Type: OTHER

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

Interventions

DFR AED Pilot Program

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monique Starks, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Daniel Mark, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Joseph Ornato, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Central Contacts

Leo Brothers, MPH

Role: CONTACT

joseph.l.brothers@duke.edu

919-641-3555

Lauren Wilverding

Role: CONTACT

lauren.wilverding@duke.edu

Other Identifiers

23HERNPRH1150361

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00113925

Identifier Type: -

Identifier Source: org_study_id