Out-of-Hospital Cardiac Arrest (Simulated)NCT07508774
Simulation and Feasibility Study of Drone-Delivered AED for Out-of-Hospital Cardiac Arrest
A study testing Drone-Based AED Delivery System and Standard Ground Ambulance Response Pathway Simulation in people with Out-of-Hospital Cardiac Arrest (Simulated), run by Ye Sheng at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest (Simulated)
- What is being tested?
- Drone-Based AED Delivery System and Standard Ground Ambulance Response Pathway Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Dec 2026
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yanguoer Zhang contact
China1 site
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Sheng Ye, +86 553 2871911, yesheng0553@126.com
Yanguoer Zhang
About this study
Official title: 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.
Read more
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.
- Being tested
- Drone-Based AED Delivery System, Standard Ground Ambulance Response Pathway Simulation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drone-Based AED Delivery SystemDevice
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.
Standard Ground Ambulance Response Pathway SimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Drone-Based AED Delivery Pathway | Experimental | 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. Receives: Device: Drone-Based AED Delivery System |
| Standard Ground Ambulance Response Pathway Simulation | Active comparator | 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. Receives: Other: Standard Ground Ambulance Response Pathway Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Unified Simulated Task Start to AED Pad Placement on the Manikin Chest
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.
Measured: Up to 30 minutes
Secondary outcomes (8)
Difference in Call-to-Pad-Placement Time Between Urban and Suburban Settings
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.
Measured: Up to 30 minutes
Difference in Call-to-Pad-Placement Time Between Peak and Off-Peak Traffic Periods
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.
Measured: Up to 30 minutes
Successful AED Delivery Rate by Drone Delivery Mode
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.
Measured: Up to 30 minutes
AED Retrieval Time by Drone Delivery Mode
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.
Measured: Up to 10 minutes
Stage-Specific Time Measures in the Drone Pathway
Includes dispatch delay, flight time, delivery delay, and volunteer pad-placement time in the drone pathway during each simulated task.
Measured: Up to 30 minutes
Stage-Specific Time Measures in the Ground Ambulance Pathway
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.
Measured: Up to 30 minutes
Actual Flight Distance per Drone Mission
Defined as the actual flight distance traveled by the drone during each mission, measured in kilometers.
Measured: During each drone mission, up to 60 minutes
Average Cruising Speed per Drone Mission
Defined as the average cruising speed of the drone during each mission, measured in kilometers per hour.
Measured: During each drone mission, up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac Arrest (Simulated)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ye Sheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ye Sheng, Second Affiliated Hospital of Wannan Medical College
- Investigators
- Sheng Ye, Principal investigator, Second Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508774
- Sponsor's protocol ID
- WYEFYLS2024147
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Drone-Delivered Automated External Defibrillators in Out-of-Hospital Cardiac Arrest: A Simulation and Feasibility Study in a Chinese City
- ClinicalTrials.gov ID
- NCT07508774
- Acronym / sponsor ID
- WYEFYLS2024147
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ye ShengUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drone-Based AED Delivery Pathway | Experimental | Device: Drone-Based AED Delivery SystemA 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. |
| Standard Ground Ambulance Response Pathway Simulation | Active comparator | Other: Standard Ground Ambulance Response Pathway SimulationA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Drone-Based AED Delivery SystemThe 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. | Device | Drone-Based AED Delivery Pathway |
| Standard Ground Ambulance Response Pathway SimulationThe 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. | Other | Standard Ground Ambulance Response Pathway Simulation |
Primary outcome
Time From Unified Simulated Task Start to AED Pad Placement on the Manikin Chest
Time frame: Up to 30 minutes
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.
8 secondary outcomes
Difference in Call-to-Pad-Placement Time Between Urban and Suburban Settings
Time frame: Up to 30 minutes
Difference in Call-to-Pad-Placement Time Between Peak and Off-Peak Traffic Periods
Time frame: Up to 30 minutes
Successful AED Delivery Rate by Drone Delivery Mode
Time frame: Up to 30 minutes
AED Retrieval Time by Drone Delivery Mode
Time frame: Up to 10 minutes
Stage-Specific Time Measures in the Drone Pathway
Time frame: Up to 30 minutes
Stage-Specific Time Measures in the Ground Ambulance Pathway
Time frame: Up to 30 minutes
Actual Flight Distance per Drone Mission
Time frame: During each drone mission, up to 60 minutes
Average Cruising Speed per Drone Mission
Time frame: During each drone mission, up to 60 minutes
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 2 Apr 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.
Yanguoer Zhang contact
Sheng Ye principal investigator
Second Affiliated Hospital of Wannan Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drone-Based AED Delivery System and Standard Ground Ambulance Response Pathway Simulation in people with Out-of-Hospital Cardiac Arrest (Simulated), run by Ye Sheng at 1 site in China.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Apr 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 China. 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 Sheng Ye (+86 553 2871911, yesheng0553@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From Unified Simulated Task Start to AED Pad Placement on the Manikin Chest (time frame: Up to 30 minutes). 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 2 Apr 2026.