Simulation and Feasibility Study of Drone-Delivered AED for Out-of-Hospital Cardiac Arrest

Официальное название

Application of Drone-Delivered Automated External Defibrillators in Out-of-Hospital Cardiac Arrest: A Simulation and Feasibility Study in a Chinese City

Обзор

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.

Вмешательства

• Устройство Drone-Based AED Delivery System
  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 oper
• Другое Standard Ground Ambulance Response Pathway Simulation
  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.

Первичные конечные точки

• Time From Unified Simulated Task Start to AED Pad Placement on the Manikin Chest [Срок оценки: Up to 30 minutes]

Вторичные конечные точки (8)

• Difference in Call-to-Pad-Placement Time Between Urban and Suburban Settings [Срок оценки: Up to 30 minutes]
• Difference in Call-to-Pad-Placement Time Between Peak and Off-Peak Traffic Periods [Срок оценки: Up to 30 minutes]
• Successful AED Delivery Rate by Drone Delivery Mode [Срок оценки: Up to 30 minutes]
• AED Retrieval Time by Drone Delivery Mode [Срок оценки: Up to 10 minutes]
• Stage-Specific Time Measures in the Drone Pathway [Срок оценки: Up to 30 minutes]
• Stage-Specific Time Measures in the Ground Ambulance Pathway [Срок оценки: Up to 30 minutes]
• Actual Flight Distance per Drone Mission [Срок оценки: During each drone mission, up to 60 minutes]
• Average Cruising Speed per Drone Mission [Срок оценки: During each drone mission, up to 60 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Wannan Medical College — Wuhu

Идентификаторы

NCT: NCT07508774 · WYEFYLS2024147

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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