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NCT07384533

Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Salvage Lung Transplantation

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Salvage Lung Transplantation: A Prospective Multicenter Single-Arm Clinical Study

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-30

Completion Date

2028-03-30

Last Updated

2026-02-03

Healthy Volunteers

Yes

Conditions

End-stage Lung Disease

Interventions

PROCEDURE

Lung transplantation that preserves spontaneous breathing function

This 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.

\[1\] 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.