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

NCT06229418 | Not Yet Recruiting

• 2 other identifiers: Pro0011392523HERNPRH1150361
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Arrest; Sudden Cardiac Arrest

Keywords

Drone; Automated External Defibrillator

Outcome Measures

Primary Outcomes (2)

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

  6 months (Aim 3a)

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

  15 months (Aim 3c)

Secondary Outcomes (9)

• Proportion of OHCA cases with drone arrival ahead of EMS arrival

  6 months (Aim 3a)

• Proportion of OHCA cases with drone arrival ahead of EMS arrival

  15 months (Aim 3c)

• Proportion of times AED was successfully deployed

  6 months (Aim 3b)

• Time from drone arrival on scene to AED delivery on the ground

  6 months (Aim 3b)

• Drone altitude at time of deployment

  6 months (Aim 3b)

Study Arms (1)

DFR AED Program

EXPERIMENTAL

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

Other: DFR AED Pilot Program

Interventions

DFR AED Pilot Program OTHER

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

DFR AED Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Virginia Commonwealth University: collaborator
• University of Toronto: collaborator
• University of Washington: collaborator

MeSH Terms

Conditions

Heart Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monique Starks, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Daniel Mark, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Joseph Ornato, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo Brothers, MPH

CONTACT

919-641-3555; joseph.l.brothers@duke.edu

Lauren Wilverding

CONTACT

lauren.wilverding@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: December 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share