Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07384533
Eligibility Criteria:
\[1\] Inclusion Criteria
1. Age and informed consent: Age ≥18 years. The participant or their legally authorized representative (LAR) is able to complete the informed consent process in a rescue/emergent transplant setting and sign written informed consent.
2. Transplant candidacy: Listed in the China Lung Transplantation Registry (CLuTR) or the lung transplant waiting list of the participating center, with a planned allogeneic lung transplantation.
3. Rescue/bridge definition (core cohort criterion): Meets any of the following conditions and is deemed by the study team to require rescue/emergent transplantation and to proceed to transplant: continuous invasive mechanical ventilation preoperatively (endotracheal intubation or tracheostomy); or preoperative extracorporeal membrane oxygenation (ECMO) / other extracorporeal life support (ECLS); or urgent escalation of support due to progressive respiratory and/or circulatory failure, entering a rescue transplant pathway.
4. Minimum key organ function: Left ventricular ejection fraction (LVEF) ≥40%; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; American Society of Anesthesiologists (ASA) Physical Status classification ≤ IV.
5. Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV meet the center's transplant requirements (e.g., undetectable viral load, as applicable).
6. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to cooperate with training) and reliable caregiving support (at least one primary caregiver).
\[2\] Exclusion Criteria
1. Informed consent/adherence: Refusal of or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or that there is repeated serious non-adherence.
2. Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation.
3. Recent major cardiovascular/cerebrovascular events: Acute coronary syndrome/myocardial infarction or stroke within the past 30 days.
4. Severe organ dysfunction/acute failure: LVEF \<40%; eGFR \<40 mL/min/1.73 m²; acute liver failure or decompensated cirrhosis/portal hypertension; acute renal failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorder or impaired consciousness.
5. High risk of severe infection: Septic shock; active extrapulmonary/disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting the center's transplant criteria).
6. High risk of major bleeding: Severe bronchiectasis not treated with preoperative vascular intervention or not readily correctable.
7. Malignancy: Active malignancy or malignancy with high risk of recurrence or cancer-related mortality.
8. Severe chest wall or spinal deformity: Deemed by the study team to compromise surgical exposure, ventilation/airway management, or perioperative safety.
9. Substance use/dependence: Current smoking, e-cigarette/vaping use, inhaled cannabis use, or intravenous drug use.
10. Tubeless/breathing-preserved strategy not safely feasible: The anesthesia team judges a difficult airway or laryngeal mask/non-intubated airway management to be unsafe (e.g., anticipated difficult airway, pharyngeal/laryngeal stenosis unsuitable for laryngeal mask, or other conditions unfavorable for airway management), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomical variation (e.g., anomalous right upper lobe bronchial origin in a planned right lung transplantation) such that safe management with a laryngeal mask or single-lumen tube is deemed unlikely.
11. Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology that the transplant team deems unacceptable.
12. Protected population: Pregnant or breastfeeding women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT07384533
Study Brief:
Protocol Section:
NCT07384533