About this trial
This prospective, single-arm study will evaluate the feasibility, timeliness, operational reliability, and preliminary safety of transporting donor lungs by a long-range unmanned aircraft system from Nanning to Guangzhou, China. Adult lung transplant candidates will be enrolled after a donor lung has been legally allocated and clinically accepted and after written informed consent has been obtained. Each formally activated transport task will use standard donor-lung perfusion and cold preservation, triple sterile packaging, and a dedicated transport container with continuous monitoring of temperature, vibration, pressure, position, and communication status. The primary outcome is the actual door-to-door transport time from the donor operating room exit to the recipient operating room entry. Secondary outcomes include transport success, time saved compared with contemporaneous ground-transport estimates, lung preservation and ischemic times, transport-environment performance, donor-lung condition on arrival, and early recipient and graft outcomes through 90 days after transplantation. Twenty-five participants corresponding to 25 formally activated donor-lung transport tasks are planned.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Cross-Regional Unmanned Aircraft Transport of Donor Lungs
Other interventionAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
Actual Door-to-Door Donor Lung Transport Time
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.
Secondary outcomes
Absolute Time Gain Compared With Contemporaneous Ground-Transport Estimate
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.
Cold Preservation Time of the First Implanted Lung
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.
Cold Preservation Time of the Second Implanted Lung
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.
Graft Survival at 30 Days
The proportion of transplanted participants alive with a functioning transplanted lung and without retransplantation at postoperative day 30 will be reported.
Sponsors and contacts
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