BREATHE Study: Spontaneous Breathing-Preserved Anesthesia and Surgical Strategy for Hospital Recovery in Lung Transplantation
Starting soon · Not applicable
Conditions studied: End-stage Lung Disease
In brief
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.
Key facts
- Study ID
- NCT07384546
- Run by
- The First Affiliated Hospital of Guangzhou Medical University
- People needed
- 110
- Starts
- 2026-01-10
- Expected to finish
- 2027-01-30
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Full record on ClinicalTrials.gov
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