Not Yet RecruitingNot Applicable

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

60 participantsStarted 2026-01-30

Plain-language 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.

Who can participate

Age range70 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Transplant candidacy: Listed in CLuTR or the lung transplant waiting list of the participating center, with a plan to undergo allogeneic lung transplantation.
✓. Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) preoperatively, and not receiving ECMO or other extracorporeal life support.
✓. 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).
✓. 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).
✓. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver).

Exclusion criteria

What they're measuring

Number of Participants Requiring Postoperative Invasive Mechanical Ventilation (IMV) During Index Hospitalization

Timeframe: From ICU admission immediately after leaving the operating room until hospital discharge or in-hospital death, assessed up to 90 days postoperatively (if hospitalization extends beyond 90 days, events after day 90 will not be counted for this outcome).

Postoperative Hospital Length of Stay (Days) During Index Hospitalization

Timeframe: From end of surgery (postoperative Day 0) until hospital discharge or in-hospital death (index hospitalization), assessed up to 90 days.

Rate of Perioperative Survival

Timeframe: From start of transplant surgery through hospital discharge or postoperative Day 30, whichever occurs first.

Trial details

NCT IDNCT07384507

SponsorThe First Affiliated Hospital of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-01

Contact for this trial

Jiaqin Zhang, M.D.

+8613662833144 zhang_jqwow@163.com

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