Clinical Trial

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

Not Yet Recruiting
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Summary
The goal of this prospective, multicenter, single-arm clinical study is to learn whether a spontaneous breathing-preserving perioperative management strategy can improve recovery and is safe in lung transplant recipients with very low body weight (body mass index \[BMI\] \<16 kg/m²). The main questions it aims to answer are whether, in lung transplant recipients with very low body weight (BMI \<16 kg/m²), a spontaneous breathing-preserving anesthesia-surgical strategy combined with standardized nutritional optimization and a prehabilitation program can improve early postoperative recovery and perioperative survival. Specifically, the study will assess the proportion of participants who require postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival within the protocol-defined time window (e.g., through hospital discharge). Participants will undergo lung transplantation using a perioperative strategy that preserves spontaneous breathing whenever clinically appropriate, with predefined criteria for conversion to endotracheal intubation and mechanical ventilation if needed. They will receive standard postoperative monitoring and supportive care, with respiratory support events and perioperative complications assessed during the index hospitalization (and up to 30 days after surgery, if specified in the protocol). Key outcomes will be collected from routine clinical care, including postoperative ventilatory support status, length of hospital stay, and major safety events.
Trial Details
NCT Number NCT07384572
Lead Sponsor The First Affiliated Hospital of Guangzhou Medical University
Conditions End-stage Lung Disease
Enrollment 56 participants
Start Date 2026-01-13
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-03