Developing and Testing Drone-Delivered AEDs for Cardiac Arrests In Rural America
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DFR AED Pilot Program.
- Who it may be relevant to
- Registry conditions: Cardiac Arrest, Sudden Cardiac Arrest. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other DFR AED Pilot Program
Integrate AED drone delivery into an existing FAA-approved drone-as-first-responder programs
Primary outcome measures
- 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)]
Secondary outcome measures (9)
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Forsyth County — Clemmons
Identifiers
NCT: NCT06229418 · Pro00113925 · 23HERNPRH1150361