Cross-Regional Unmanned Aircraft Transport of Donor Lungs (UAV-LUNG)
Feasibility and Timeliness of Cross-Regional Unmanned Aircraft Transport of Donor Lungs: A Prospective Single-Arm Clinical Study
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The study will be conducted between the Second Affiliated Hospital of Guangxi Medical University in Nanning, the donor-lung transport origin, and the First Affiliated Hospital of Guangzhou Medical University, Datansha Campus, the receiving and transplant center. The planned route is approximately 570 km. The study does not include a concurrent physical ground-transport arm. For each activated task, real-time estimated arrival times for ground transport will be obtained from two prespecified map platforms at the same origin, destination, and reference time. These estimates are an external task-level benchmark for transport efficiency and will not be interpreted as a randomized or parallel clinical control.
Each formally activated task is the primary operational unit of analysis. A bilateral donor-lung shipment intended for one recipient is counted as one task. After clinical acceptance of the donor lung and confirmation of participant eligibility, the lung will undergo standard perfusion, cold preservation, triple sterile packaging, identity verification, and loading into a validated transport container. The unmanned aircraft will fly an approved route under continuous flight and environmental monitoring. A ground backup transport plan will remain available. If medical, weather, airspace, aircraft, communication, energy, or landing-site conditions become unacceptable, the task may be delayed, canceled, returned, diverted, or transferred to ground transport. All activated tasks, including tasks that do not take off or do not complete unmanned transport, will remain in the transport-task analysis set.
The primary outcome is actual door-to-door donor-lung transport time, calculated in minutes from the time the lung exits the donor operating room (T1) to the time it enters the recipient operating room (T6). Key secondary outcomes include the proportion of activated tasks completed successfully, absolute and relative time gain versus contemporaneous ground-transport estimates, lung preservation and ischemic times, temperature stability, vibration and shock, pressure change, communication-link availability, packaging integrity, and donor-lung utilization. Recipients who undergo transplantation with a study-transported donor lung will be evaluated for primary graft dysfunction, perioperative complications, intensive care and hospital length of stay, graft survival, and participant survival through postoperative day 90.
Donor-lung acceptance, recipient selection, transplantation, and postoperative treatment will follow routine clinical standards and will remain independent of study efficiency targets. Prespecified pause rules include any catastrophic transport event, loss or non-recovery of the donor lung, a clearly transport-related organ discard, a serious aviation accident, or a participant death considered clearly or highly likely related to the transport intervention.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jiaqin Zhang, M.D.
- Номер телефона: 13662833144
- Электронная почта: zhang_jqwow@163.com
Места учебы
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Guangdong
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Guangzhou, Guangdong, Китай, 510163
- The First Affiliated Hospital of Guangzhou Medical University, Datansha Campus
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Контакт:
- Jiaqin Zhang
- Номер телефона: 13662833144
- Электронная почта: zhang_jqwow@163.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria
- The donor lung has been donated, allocated, procured, and assigned in accordance with applicable Chinese laws, regulations, allocation rules, and ethical requirements, and has been allocated to a lung transplant candidate at the First Affiliated Hospital of Guangzhou Medical University.
- The donor lung is considered clinically suitable for transplantation by both the procurement team and the recipient transplant team and is intended for single or bilateral lung transplantation.
- The donor-lung procurement location, transplant location, and transport route conform to the prespecified Nanning-to-Guangzhou cross-regional unmanned-aircraft scenario.
- After standard perfusion, cold preservation, and triple sterile packaging, the donor-lung package meets the transport-container and aircraft requirements for weight, dimensions, fixation, and preservation.
- The participant is 18 years of age or older, meets clinical indications for lung transplantation, and is considered medically suitable to undergo single or bilateral lung transplantation.
- The participant or legally authorized representative has provided written informed consent for the study before formal task activation.
- Before activation, the aircraft, propulsion, navigation, communication, monitoring equipment, landing sites, weather, airspace, route, energy reserve, and backup transport plan meet prespecified operational criteria.
- The main transport timestamps, environmental and flight-engineering data, and participant follow-up through postoperative day 90 are expected to be obtainable.
Exclusion Criteria
- The donor lung is considered unsuitable for transplantation or has been definitively declined before task activation.
- The donation, allocation, procurement, transport, or transplantation process does not comply with applicable legal, ethical, institutional, or protocol requirements.
- The packaged donor lung does not meet aircraft or transport-container requirements for weight, dimensions, fixation, packaging, or preservation.
- The participant is younger than 18 years.
- The participant is planned for combined heart-lung transplantation, another multi-organ transplantation, or repeat lung transplantation.
- The participant is clinically unstable, the transplant procedure has been canceled or materially changed, or the transplant team considers the participant unsuitable to proceed with transplantation.
- The participant or legally authorized representative declines participation or valid informed consent cannot be obtained.
- Before task activation, weather, airspace, route, landing site, aircraft, propulsion, navigation, communication, monitoring, or energy-reserve conditions fail to meet prespecified operational criteria.
- A reliable backup transport plan cannot be established, or the study team determines that unmanned-aircraft transport would create an unacceptable risk of donor-lung loss, delay, contamination, or damage.
- Complete primary timestamps or key engineering parameters are not expected to be obtainable, or postoperative day-90 follow-up is not expected to be feasible.
- The investigator identifies another medical, ethical, operational, or safety reason that makes study participation inappropriate.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Unmanned Aircraft Donor Lung Transport
Participants in this single study arm are adult lung transplant candidates whose allocated donor lung will undergo standard perfusion, cold preservation, triple sterile packaging, and transport from Nanning to Guangzhou by a long-range unmanned aircraft system.
Flight and donor-lung transport conditions will be continuously monitored.
Donor-lung acceptance, transplantation, and postoperative care will follow routine clinical standards.
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After clinical acceptance and standard donor-lung preservation, the packaged donor lung will be placed in a dedicated transport container and carried by a long-range vertical-takeoff-and-landing unmanned aircraft along an approved cross-regional route.
The task includes identity verification, loading, monitored flight, unloading, medical handover, and transfer to the recipient operating room.
Temperature, three-axis acceleration, pressure, humidity, position, communication, and aircraft operating parameters will be recorded.
A predefined backup transport plan and task cancellation, return, diversion, and ground-relay procedures will be available throughout the task.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Actual Door-to-Door Donor Lung Transport Time
Временное ограничение: During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)
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Actual door-to-door transport time will be calculated in minutes as T6 minus T1.
The interval includes donor-hospital internal transfer, loading and handover, any pre-takeoff waiting after T1, flight, unloading, recipient-hospital handover, and internal transfer to the recipient operating room.
Synchronized electronic timestamps will be used preferentially; a jointly verified manual record will be used if automated sources fail.
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During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Absolute Time Gain Compared With Contemporaneous Ground-Transport Estimate
Временное ограничение: At completion of each donor-lung transport task (recipient operating room entry, T6)
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For each of two prespecified map platforms, absolute time gain will be calculated in minutes as the platform-specific contemporaneous ground-transport estimated duration minus the actual unmanned-aircraft door-to-door transport time.
Results from the two platforms will be reported separately; a positive value indicates time saved.
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At completion of each donor-lung transport task (recipient operating room entry, T6)
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Cold Preservation Time of the First Implanted Lung
Временное ограничение: From the start of cold perfusion (T0) to the end of cold preservation for the first implanted lung (T7a0)
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Cold preservation time for the first implanted lung will be calculated in minutes as T7a0 minus T0.
For single-lung transplantation, the implanted lung will be analyzed as the first implanted lung.
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From the start of cold perfusion (T0) to the end of cold preservation for the first implanted lung (T7a0)
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Cold Preservation Time of the Second Implanted Lung
Временное ограничение: From the start of cold perfusion (T0) to the end of cold preservation for the second implanted lung (T7b0)
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For bilateral lung transplantation, cold preservation time for the second implanted lung will be calculated in minutes as T7b0 minus T0.
This outcome is not applicable to single-lung transplantation.
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From the start of cold perfusion (T0) to the end of cold preservation for the second implanted lung (T7b0)
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Graft Survival at 30 Days
Временное ограничение: 30 days after lung transplantation
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The proportion of transplanted participants alive with a functioning transplanted lung and without retransplantation at postoperative day 30 will be reported.
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30 days after lung transplantation
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UAV-LUNG-001
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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