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BREATHE Study: Spontaneous Breathing-Preserved Anesthesia and Surgical Strategy for Hospital Recovery in Lung Transplantation

NCT07384546 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-03

No results posted yet for this study

Summary

The goal of this study is to learn whether a spontaneous-breathing ("tubeless") anesthesia and surgery strategy can improve early recovery and remain safe for adults who receive a lung transplant. This strategy aims to help lung transplant recipients maintain spontaneous breathing as much as possible during and after surgery, avoid tracheal intubation with invasive mechanical ventilation and deep sedation, and thereby support faster recovery while maintaining postoperative survival and safety. All participants will receive lung transplantation supported by the same spontaneous-breathing ("tubeless") strategy. Researchers plan to enroll about 110 participants at several hospitals in China. A separate study team will review the main outcomes using predefined study rules.

The main questions this study aims to answer are: The main questions this study aims to answer are: among adult lung transplant recipients, does an anesthesia-surgical strategy that preserves spontaneous breathing improve early postoperative recovery while remaining safe during the first 30 days after surgery? The study will focus on the need for postoperative invasive mechanical ventilation, length of postoperative hospital stays, and in-hospital mortality.

Participants will: Complete screening tests and assessments before surgery (up to about 30 days before the transplant). Undergo lung transplantation using a standardized approach that aims to keep spontaneous breathing function, often using a laryngeal mask airway instead of a breathing tube. Receive pain and cough control measures (such as local anesthesia or nerve block anesthesia) and close monitoring during and after surgery. Receive standard postoperative care. If safety concerns arise, the clinical team will use invasive mechanical ventilation or extracorporeal membrane oxygenation when needed. Be followed during the hospital stay and for 90 days after surgery to record recovery, complications, and readmissions.

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2027-01-15
Completion
2027-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07384546 on ClinicalTrials.gov