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NCT07384507

Perioperative Recovery Outcomes With a Spontaneous Breathing Strategy in Older Lung Transplant Recipients

Sponsor: The First Affiliated Hospital of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

The goal of this prospective, multicenter, single-arm cohort study is to learn whether a lung transplantation approach that preserves patients' spontaneous breathing during surgery can improve early recovery in adults aged 70 years and older undergoing allogeneic lung transplantation. The main questions it aims to answer are whether, in adult lung transplant recipients aged 70 years and older, an anesthesia-surgical strategy designed to preserve spontaneous breathing is associated with better early postoperative recovery, specifically in terms of the need for postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival. Participants will undergo lung transplantation using a standardized anesthesia-surgical strategy intended to preserve spontaneous breathing, with predefined criteria for conversion to tracheal intubation and/or ECMO if clinically needed. They will receive standardized perioperative management and routine postoperative care (including ICU monitoring, rehabilitation, and recovery support) as determined by the transplant team. Participants will be assessed throughout hospitalization and followed for postoperative complications and outcomes through discharge and up to 30 days after surgery.

Official title: Evaluation of Perioperative Recovery With a Spontaneous Breathing-Preserving Strategy in Older Lung Transplant Recipients: A Prospective Multicenter Single-Arm Cohort Study

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-30

Completion Date

2029-01-30

Last Updated

2026-02-03

Healthy Volunteers

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 ≥70 years; able to understand the study and provide written informed consent, or, where permitted by ethics and applicable regulations, consent may be provided by a legally authorized representative (LAR)/authorized surrogate; willing and able to complete follow-up. 2. Transplant candidacy: Listed in CLuTR or the lung transplant waiting list of the participating center, with a plan to undergo allogeneic lung transplantation. 3. Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) preoperatively, and not receiving ECMO or other extracorporeal life support. 4. Minimum key organ function: LVEF ≥40%; eGFR ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; ASA physical status ≤ IV (American Society of Anesthesiologists classification). 5. Infection and communicable diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meets the center's transplant requirements (e.g., undetectable viral load, as applicable). 6. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver). \[2\] Exclusion Criteria 1. Informed consent/adherence: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or there is recurrent severe non-adherence. 2. Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation. 3. Recent major cardio-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 disorders or altered 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 bleeding risk: Severe bronchiectasis without preoperative vascular intervention or not correctable/mitigable. 7. Malignancy: Active malignancy or tumors with high risk of recurrence or high cancer-related mortality risk. 8. Extreme body habitus/major deformity: BMI ≥35 kg/m² or BMI \<16 kg/m²; clearly diagnosed severe chest wall deformity or spinal deformity. 9. Substance use/dependence: Current use of cigarettes, e-cigarettes, smoked/vaped cannabis, or intravenous drug use. 10. Tubeless/spontaneous-breathing strategy not safely feasible: Deemed by the anesthesia team to have a difficult airway or unsafe supraglottic/non-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal/laryngeal stenosis not suitable for a laryngeal mask), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomical variations (e.g., aberrant right upper lobe bronchial takeoff with planned right lung transplantation) where safe management with LMA/single-lumen approaches is judged unlikely. 11. Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology considered unacceptable by the transplant team. 12. Protected populations: Pregnant or breastfeeding women.