- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07508774
Simulation and Feasibility Study of Drone-Delivered AED for Out-of-Hospital Cardiac Arrest
Application of Drone-Delivered Automated External Defibrillators in Out-of-Hospital Cardiac Arrest: A Simulation and Feasibility Study in a Chinese City
Background: Survival after out-of-hospital cardiac arrest (OHCA) depends heavily on early defibrillation. Reducing the time from cardiac arrest to defibrillation is a key factor in improving survival. In recent years, many countries have promoted early defibrillation through public automated external defibrillator (AED) networks. However, in practice, public access to and use of AEDs remain limited because of insufficient accessibility, uneven distribution, difficulties in locating devices, and delays in retrieval. With the development of drone technology, rapid drone-based AED delivery has been considered a potentially promising solution. Drones may bypass ground traffic congestion and reach the scene more quickly via aerial routes, allowing bystanders to use an AED under remote guidance. Although simulation studies, system optimization studies, and preliminary real-world applications of drone-delivered AEDs have been reported in other countries, this field remains exploratory in China. At present, most Chinese cities still rely mainly on conventional ambulance dispatch systems and fixed AED networks, both of which may be limited by urban traffic congestion, high population density, and uneven spatial distribution of AEDs.
Objective: This prospective quasi-real-world simulation study in Wuhu, Anhui Province, China, aims to compare the time efficiency of a drone-based AED delivery pathway with that of a standard ground ambulance response pathway in simulated OHCA scenarios. The study will also evaluate the effects of geographic setting, traffic period, and different aerial delivery modes on delivery performance, in order to provide preliminary evidence for the deployment of drone-assisted emergency response networks in Chinese cities.
Methods: This is an open-label, non-randomized, exploratory pilot feasibility study. The drone launch site will be located at a designated takeoff and landing area near the Emergency Department building of the Second Affiliated Hospital of Wannan Medical College. Simulated task endpoints will be selected within a 30-km one-way mission radius from the launch site. The study includes three sub-studies: (1) comparison of response efficiency between the drone pathway and the ground ambulance pathway in urban versus suburban locations; (2) comparison of response efficiency between the drone pathway and the ground ambulance pathway during peak versus off-peak traffic periods; and (3) comparison of operational time and success rate among three drone AED delivery modes, including winch lowering, low-altitude compartment retrieval, and direct landing. A total of 24 healthy volunteers will participate in the simulation tasks, and 1 to 3 professional drone operators will conduct flight operations. For each simulated task, a unified start command will be issued by the study coordinator, and the volunteer will receive the AED and complete electrode pad placement on the manikin.
Primary Outcome: The primary outcome is the time from the unified simulated task start to completion of AED pad placement on the manikin chest.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sheng Ye
- Phone Number: +86 553 2871911
- Email: yesheng0553@126.com
Study Contact Backup
- Name: Yanguoer Zhang
Study Locations
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Anhui
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Wuhu, Anhui, China
- The Second Affiliated Hospital of Wannan Medical College
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Contact:
- Sheng Ye
- Phone Number: +86 553 2871911
- Email: yesheng0553@126.com
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Contact:
- Yanguoer Zhang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 65 years
- Able to understand the study purpose and simulation procedures and provide informed consent
- Able to communicate adequately and cooperate with outdoor simulation tasks
- Able to walk independently and perform basic upper-limb operations
- Able to complete standardized training and pass a basic AED simulation skills assessment before participation
Exclusion Criteria:
- History of severe cardiovascular, respiratory, or neurological disease that, in the investigator's judgment, makes participation in outdoor simulation tasks unsuitable
- Significant musculoskeletal disease or injury affecting mobility, object retrieval, or pad placement
- Significant visual, auditory, or cognitive impairment that may interfere with task performance
- Marked fear of, discomfort with, or unwillingness to participate in low-altitude drone-related activities
- Any other condition judged by the investigator to make participation inappropriate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Drone-Based AED Delivery Pathway
A simulated emergency response pathway in which a drone carries and delivers an AED training device from a designated launch site to a simulated OHCA location.
Depending on the sub-study, delivery may be performed by winch lowering, low-altitude compartment retrieval, or direct landing.
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The drone platform is a DJI M400 operating along pre-specified flight routes and carrying a lightweight AED training device.
The AED device used in this study is a Mindray BeneHeart series AED trainer, which is a simulation device rather than a live AED.
Depending on the sub-study, one of three delivery modes will be used: winch lowering, low-altitude compartment retrieval, or direct landing.
The mission will primarily be executed automatically based on preset flight routes, while the drone operator will monitor the mission and take over when necessary for safety or contingency management.
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Active Comparator: Standard Ground Ambulance Response Pathway Simulation
A simulated emergency response pathway modeled on the local standard prehospital ambulance workflow.
After receiving the unified simulated task start command, a standard ambulance with a fixed crew travels along a predetermined route to the simulated endpoint, and the on-site volunteer retrieves the AED training device from the ambulance and completes electrode pad placement on the manikin.
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The control pathway will be simulated using a standard ambulance, a fixed ambulance crew, and a predefined operational workflow modeled on the local standard prehospital emergency response process.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time From Unified Simulated Task Start to AED Pad Placement on the Manikin Chest
Time Frame: Up to 30 minutes
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Defined as the elapsed time from issuance of the unified simulated task start command by the study coordinator to completion of standard placement of both AED pads on the manikin chest.
Time points will be recorded by the lead timekeeper using a standardized timing tool.
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Up to 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference in Call-to-Pad-Placement Time Between Urban and Suburban Settings
Time Frame: Up to 30 minutes
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Defined as the difference in elapsed time from the unified simulated task start to completion of AED pad placement on the manikin chest between urban and suburban scenarios in Sub-study 1, comparing the drone pathway with the standard ground ambulance response pathway.
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Up to 30 minutes
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Difference in Call-to-Pad-Placement Time Between Peak and Off-Peak Traffic Periods
Time Frame: Up to 30 minutes
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Defined as the difference in elapsed time from the unified simulated task start to completion of AED pad placement on the manikin chest between peak and off-peak traffic scenarios in Sub-study 2, comparing the drone pathway with the standard ground ambulance response pathway.
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Up to 30 minutes
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Successful AED Delivery Rate by Drone Delivery Mode
Time Frame: Up to 30 minutes
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Defined as the proportion of simulation tasks in Sub-study 3 in which the AED training device is successfully delivered to the designated volunteer according to the predefined workflow and is available for retrieval without safety-related interruption.
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Up to 30 minutes
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AED Retrieval Time by Drone Delivery Mode
Time Frame: Up to 10 minutes
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Defined as the elapsed time from drone arrival above the target area or at the landing point to successful retrieval of the AED training device by the designated volunteer in Sub-study 3.
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Up to 10 minutes
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Stage-Specific Time Measures in the Drone Pathway
Time Frame: Up to 30 minutes
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Includes dispatch delay, flight time, delivery delay, and volunteer pad-placement time in the drone pathway during each simulated task.
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Up to 30 minutes
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Stage-Specific Time Measures in the Ground Ambulance Pathway
Time Frame: Up to 30 minutes
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Includes dispatch delay, driving time, AED retrieval delay, and volunteer pad-placement time in the ground ambulance pathway during each simulated task in Sub-studies 1 and 2.
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Up to 30 minutes
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Actual Flight Distance per Drone Mission
Time Frame: During each drone mission, up to 60 minutes
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Defined as the actual flight distance traveled by the drone during each mission, measured in kilometers.
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During each drone mission, up to 60 minutes
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Average Cruising Speed per Drone Mission
Time Frame: During each drone mission, up to 60 minutes
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Defined as the average cruising speed of the drone during each mission, measured in kilometers per hour.
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During each drone mission, up to 60 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheng Ye, The Second Affiliated Hospital of Wannan Medical College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WYEFYLS2024147
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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