Clinical trial NCT06229418: Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
Official title: Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Sudden Cardiac Arrest
Keywords: Drone
Automated External Defibrillator
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
name: University of Toronto
name: University of Washington
First posted: 2024-01-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
timeFrame: 6 months (Aim 3a)
measure: Time interval difference between AED arrival of drones versus law/fire/EMS arrival to the OCHA scene
timeFrame: 15 months (Aim 3c)
Secondary outcomes:
measure: Proportion of OHCA cases with drone arrival ahead of EMS arrival
timeFrame: 6 months (Aim 3a)
measure: Proportion of OHCA cases with drone arrival ahead of EMS arrival
timeFrame: 15 months (Aim 3c)
measure: Proportion of times AED was successfully deployed
timeFrame: 6 months (Aim 3b)
measure: Time from drone arrival on scene to AED delivery on the ground
timeFrame: 6 months (Aim 3b)
measure: Drone altitude at time of deployment
timeFrame: 6 months (Aim 3b)
measure: Rates of bystander AED application
timeFrame: 15 months (Aim 3c)
measure: Proportions of initial shockable rhythm
timeFrame: 15 months (Aim 3c)
measure: Proportion of bystander defibrillation
timeFrame: 15 months (Aim 3c)
measure: Proportion of first responder defibrillation
timeFrame: 15 months (Aim 3c)
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Monique Starks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Daniel Mark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Joseph Ornato, MD
role: PRINCIPAL_INVESTIGATOR
References: