Starting soon
Not applicable
Cross-Regional Unmanned Aircraft Transport of Donor Lungs
Condition(s) studied
Chronic Obstructive Pulmonary Disease (COPD)Interstitial Lung Disease (ILD)End-stage Lung Disease
Investigational drug(s) / intervention(s)
Cross-Regional Unmanned Aircraft Transport of Donor Lungs
Cross-Regional Unmanned Aircraft Transport of Donor Lungs: 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.
Study summary
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
Inclusion Criteria
1. 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.
2. 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.
3. The donor-lung procurement location, transplant location, and transport route conform to the prespecified Nanning-to-Guangzhou cross-regional unmanned-aircraft scenario.
4. 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.
5. 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.
6. The participant or legally authorized representative has provided written informed consent for the study before formal task activation.
7. Before activation, the aircraft, propulsion, navigation, communication, monitoring equipment, landing sites, weather, airspace, route, energy reserve, and backup transport plan meet prespecified operational criteria.
8. The main transport timestamps, environmental and flight-engineering data, and participant follow-up through postoperative day 90 are expected to be obtainable.
Exclusion Criteria
1. The donor lung is considered unsuitable for transplantation or has been definitively declined before task activation.
2. The donation, allocation, procurement, transport, or transplantation process does not comply with applicable legal, ethical, institutional, or protocol requirements.
3. The packaged donor lung does not meet aircraft or transport-container requirements for weight, dimensions, fixation, packaging, or preservation.
4. The participant is younger than 18 years.
5. The participant is planned for combined heart-lung transplantation, another multi-organ transplantation, or repeat lung transplantation.
6. 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.
7. The participant or legally authorized representative declines participation or valid informed consent cannot be obtained.
8. Before task activation, weather, airspace, route, landing site, aircraft, propulsion, navigation, communication, monitoring, or energy-reserve conditions fail to meet prespecified operational criteria.
9. 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.
10. 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.
11. The investigator identifies another medical, ethical, operational, or safety reason that makes study participation inappropriate.
Primary outcome measure(s)
- Actual Door-to-Door Donor Lung Transport Time — During each transport task, from donor operating room exit (T1) to recipient operating room entry (T6)
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Guangzhou Medical University, Datansha Campus |
Guangzhou |
Guangdong |
|
More The First Affiliated Hospital of Guangzhou Medical University trials in China
Other trials for the same condition