NCT07384533

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Detailed description

Purpose: Rescue/bridge lung transplantation recipients represent a high-risk population with limited physiologic reserve and a high likelihood of prolonged postoperative support. This prospective, multicenter, single-arm clinical study (BREATH-Rescue) aims to evaluate the clinical effectiveness and perioperative safety of a breathing-preserved anesthesia-surgical strategy designed to minimize exposure to invasive mechanical ventilation while maintaining adequate gas exchange and hemodynamic stability. The study focuses on early postoperative recovery and perioperative survival, with primary outcomes centered on postoperative invasive mechanical ventilation (IMV) requirement, postoperative hospital length of stay (LOS), and perioperative survival through hospital discharge or 30 days after surgery (whichever occurs first). Study Design and Methods: BREATH-Rescue will enroll approximately 40 adult (≥18 years) rescue/bridge lung transplant candidates across multiple centers, with an anticipated \~36 participants contributing evaluable data for primary endpoint analyses. Rescue/bridge status is defined by meeting any of the following conditions prior to transplantation: ongoing invasive mechanical ventilation (endotracheal tube or tracheostomy), receipt of ECMO/other extracorporeal life support (ECLS), or urgent escalation of support due to progressive respiratory and/or circulatory failure prompting an emergency transplant pathway. Key baseline organ function thresholds are applied (e.g., LVEF ≥40%, eGFR ≥40 mL/min/1.73 m²), with exclusion of active uncontrolled infection. All participants will undergo lung transplantation under a standardized breathing-preserved anesthesia-surgical pathway. The strategy emphasizes preservation or early restoration of spontaneous breathing when feasible, use of a laryngeal mask airway-based approach and intravenous anesthesia with multimodal analgesia/regional techniques, and continuous physiologic monitoring. Predefined criteria guide prompt conversion to endotracheal intubation and/or initiation or escalation of extracorporeal support when clinically necessary (e.g., inadequate oxygenation/ventilation, severe hypercapnia/acidosis, hemodynamic instability, major airway bleeding, insufficient operative exposure, or airway device failure). Postoperatively, participants will receive standardized perioperative management per center transplant pathways. Outcomes and safety events will be collected from screening through hospital discharge and up to 30 days after surgery, including key complications (e.g., primary graft dysfunction graded at 0/24/48/72 hours, respiratory support events such as re-intubation/tracheostomy/new or escalated ECMO, infections, bleeding requiring re-intervention, acute kidney injury, rejection episodes, and thrombotic events). The primary endpoint is a composite of three early recovery metrics (reported both as a composite and as individual components): postoperative IMV requirement, postoperative LOS, and perioperative survival. Anticipated Results: Investigators hypothesize that, in rescue/bridge lung transplant recipients, implementation of a breathing-preserved anesthesia-surgical strategy will increase the proportion of patients who do not require postoperative IMV, shorten postoperative hospital LOS, and achieve an acceptable perioperative survival rate through discharge or 30 days, compared with participating centers' historical outcomes under conventional intubated strategies. The study is expected to generate pragmatic, multicenter evidence on feasibility, safety signals (including conversion/intubation and ECMO escalation rates), and recovery trajectories in this high-risk population, thereby informing pathway standardization and the design of future controlled comparative studies.

Conditions

• End-stage Lung Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-30
• Primary completion: 2028-01-01
• Completion: 2028-03-30
• First posted: 2026-02-03
• Last updated: 2026-02-03