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

Cardiac Arrest Clinical Trial

— RESTORe-CARE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06229418
• Other study ID #: Pro00113925
• Secondary ID: 23HERNPRH1150361
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: March 31, 2027

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Kimberly Ward, MPH
• Phone: 919-660-6409
• Email: kimberly.t.ward[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Death, Sudden, Cardiac
• Heart Arrest
• Sudden Cardiac Arrest

Intervention

Other:
• DFR AED Pilot Program
Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	University of Toronto, University of Washington, Virginia Commonwealth University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene		6 months (Aim 3a)
Primary	Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene		15 months (Aim 3c)
Secondary	Proportion of OHCA cases with drone arrival ahead of EMS arrival		6 months (Aim 3a)
Secondary	Proportion of OHCA cases with drone arrival ahead of EMS arrival		15 months (Aim 3c)
Secondary	Proportion of times AED was successfully deployed		6 months (Aim 3b)
Secondary	Time from drone arrival on scene to AED delivery on the ground		6 months (Aim 3b)
Secondary	Drone altitude at time of deployment		6 months (Aim 3b)
Secondary	Rates of bystander AED application		15 months (Aim 3c)
Secondary	Proportions of initial shockable rhythm		15 months (Aim 3c)
Secondary	Proportion of bystander defibrillation		15 months (Aim 3c)
Secondary	Proportion of first responder defibrillation		15 months (Aim 3c)