Cardiac ArrestRESTORe-CARENCT06229418
Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
A study testing DFR AED Pilot Program in people with Cardiac Arrest and Sudden Cardiac Arrest, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Sudden Cardiac Arrest
- What is being tested?
- DFR AED Pilot Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients in the CARES registry who have a traumatic cause of cardiac arrest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lauren Wilverding contact
United States1 site, 1 recruiting
- Recruiting
Forsyth County
Clemmons, North Carolina, 27012
Leo Brothers, MPH, 919-668-8322, joseph.l.brothers@duke.edu
Lauren Wilverding, lauren.wilverding@duke.edu
About this study
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.
Read the 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
- Being tested
- DFR AED Pilot Program
- Keywords
- Drone, Automated External Defibrillator
- Medical subject headings
- Heart Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFR AED Pilot ProgramOther
Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs
| Study group | Role | What they receive |
|---|---|---|
| DFR AED Program | Experimental | Real-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban) Receives: Other: DFR AED Pilot Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Measured: 6 months (Aim 3a)
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Measured: 15 months (Aim 3c)
Secondary outcomes (9)
Proportion of OHCA cases with drone arrival ahead of EMS arrival
Measured: 6 months (Aim 3a)
Proportion of OHCA cases with drone arrival ahead of EMS arrival
Measured: 15 months (Aim 3c)
Proportion of times AED was successfully deployed
Measured: 6 months (Aim 3b)
Time from drone arrival on scene to AED delivery on the ground
Measured: 6 months (Aim 3b)
Drone altitude at time of deployment
Measured: 6 months (Aim 3b)
Rates of bystander AED application
Measured: 15 months (Aim 3c)
Proportions of initial shockable rhythm
Measured: 15 months (Aim 3c)
Proportion of bystander defibrillation
Measured: 15 months (Aim 3c)
Proportion of first responder defibrillation
Measured: 15 months (Aim 3c)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, University of Toronto, University of Washington
- Responsible party
- Sponsor
- Investigators
- Monique Starks, MD, Principal investigator, Duke UniversityDaniel Mark, MD, Principal investigator, Duke UniversityJoseph Ornato, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229418
- Sponsor's protocol ID
- Pro00113925
- Other IDs
- 23HERNPRH1150361
- Acronym
- RESTORe-CARE
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
- ClinicalTrials.gov ID
- NCT06229418
- Acronym / sponsor ID
- RESTORe-CARE / Pro00113925
- Conditions
- Cardiac Arrest, Sudden Cardiac Arrest
- Keywords
- Drone, Automated External Defibrillator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, University of Toronto, University of Washington
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFR AED Program | Experimental | Other: DFR AED Pilot ProgramReal-time and simulated out-of-hospital cardiac arrests that occur across 6 communities (4 rural, 2 urban) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients in the CARES registry who have a traumatic cause of cardiac arrest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFR AED Pilot ProgramIntegrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs | Other | DFR AED Program |
Primary outcome
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
Time frame: 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)
9 secondary outcomes
Proportion of OHCA cases with drone arrival ahead of EMS arrival
Time frame: 6 months (Aim 3a)
Proportion of OHCA cases with drone arrival ahead of EMS arrival
Time frame: 15 months (Aim 3c)
Proportion of times AED was successfully deployed
Time frame: 6 months (Aim 3b)
Time from drone arrival on scene to AED delivery on the ground
Time frame: 6 months (Aim 3b)
Drone altitude at time of deployment
Time frame: 6 months (Aim 3b)
Rates of bystander AED application
Time frame: 15 months (Aim 3c)
Proportions of initial shockable rhythm
Time frame: 15 months (Aim 3c)
Proportion of bystander defibrillation
Time frame: 15 months (Aim 3c)
Proportion of first responder defibrillation
Time frame: 15 months (Aim 3c)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Wilverding contact
Monique Starks, MD principal investigator
Duke University
Daniel Mark, MD principal investigator
Duke University
Joseph Ornato, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFR AED Pilot Program in people with Cardiac Arrest and Sudden Cardiac Arrest, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leo Brothers, MPH (919-641-3555, joseph.l.brothers@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene (time frame: 6 months (Aim 3a)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.