The goal of this prospective, multicenter, single-arm clinical study is to learn whether a breathing-preserved anesthesia-surgical strategy can improve early recovery and perioperative survival in adults undergoing rescue/bridge lung transplantation.
The main questions it aims to answer are whether, in adult rescue lung transplant recipients, a breathing-preserved anesthesia-surgical strategy can improve early postoperative recovery and perioperative survival, with a focus on the need for postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival outcomes.
Participants will undergo lung transplantation using a standardized breathing-preserved anesthesia-surgical pathway, with predefined criteria for conversion to endotracheal intubation and/or initiation or escalation of extracorporeal support when clinically necessary. Participants will receive standardized perioperative care per each participating center's transplant pathways and will be followed from screening through hospital discharge and up to 30 days after surgery. Routine perioperative data and key postoperative outcomes, including major complications (e.g., graft dysfunction, respiratory support events, infections, bleeding requiring re-intervention, acute kidney injury, rejection, and thrombotic events), will be collected.
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.
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.
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.
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).
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.
Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation.
Recent major cardiovascular/cerebrovascular events: Acute coronary syndrome/myocardial infarction or stroke within the past 30 days.
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.
Single group
Lung transplantation that preserves spontaneous breathing function
Procedure/SurgeryThis intervention uses a spontaneous-breathing-preserving anesthesia strategy during lung transplantation, which differs from conventional management based on endotracheal intubation and invasive mechanical ventilation. A supraglottic airway (laryngeal mask airway) is used when feasible instead of endotracheal intubation to maintain spontaneous breathing throughout the procedure. Neuromuscular blocking agents are minimized, and regional nerve blocks (such as intercostal nerve blocks or paravertebral blocks) are used to control pain and suppress cough while preserving the patient's ability to breathe independently. After surgery, patients receive protocol-guided noninvasive respiratory support (for example, high-flow nasal oxygen or noninvasive ventilation), with the goal of avoiding routine invasive mechanical ventilation.
Number of Participants Requiring Postoperative Invasive Mechanical Ventilation (IMV) During Index Hospitalization
Number of participants who require postoperative invasive mechanical ventilation (IMV) delivered via an endotracheal tube or tracheostomy tube at any time after leaving the operating room and before hospital discharge (including in-hospital death). Time Frame: From post-anesthesia care/ICU admission (immediately after leaving the operating room) through hospital discharge or in-hospital death (index hospitalization)
Postoperative Hospital Length of Stay (Days) During Index Hospitalization
The number of days from the end of surgery (postoperative Day 0) to the date the participant is discharged from the index hospitalization, according to institutional discharge criteria. Participants who die in hospital will be assigned length of stay through the date of in-hospital death.
Rate of Perioperative Survival
Perioperative survival is defined as the proportion of participants who remain alive from the start of transplant surgery through hospital discharge or postoperative Day 30, whichever occurs first. Participants who die before discharge or before postoperative Day 30 will be counted as non-survivors for this outcome.
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