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

NCT07384546 | Not Yet Recruiting DMC

• 1 other identifier: BREATHE-LTx-Study
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Lung transplantation; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (3)

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

  Number of participants who require postoperative invasive mechanical ventilation (IMV) delivered via an endotracheal tube or tracheostomy tube at any time after leaving the operating room and before hospital discharge (including in-hospital death).

  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

  the number of days from the end of surgery (postoperative Day 0) to the date the participant is discharged from the index hospitalization, according to institutional discharge criteria. Participants who die in hospital will be assigned length of stay through the date of in-hospital death.

  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

  Perioperative survival is defined as the proportion of participants who remain alive from the start of transplant surgery through hospital discharge or postoperative Day 30, whichever occurs first. Participants who die before discharge or before postoperative Day 30 will be counted as non-survivors for this outcome.

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

Study Arms (1)

Tubeless LTx Group

EXPERIMENTAL

Single-group arm. All participants receive lung transplantation under a standardized spontaneous-breathing-preserving ("tubeless") pathway. After anesthesia induction, a supraglottic airway (laryngeal mask airway) is used when feasible with regional nerve blocks and multimodal sedation/analgesia to control pain and cough while maintaining spontaneous breathing. Muscle relaxants are minimized; ventilatory assistance is provided only as needed with low airway pressures. Postoperatively, patients are managed in the intensive care unit with spontaneous breathing and protocol-guided noninvasive respiratory support. Conversion to endotracheal intubation, invasive mechanical ventilation, and/or extracorporeal membrane oxygenation is allowed if predefined safety criteria are met.

Procedure: Lung transplantation that preserves spontaneous breathing function

Interventions

Lung transplantation that preserves spontaneous breathing function PROCEDURE

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.

Tubeless LTx Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and informed consent: Aged 18-70 years; able to understand the study and provide written informed consent; willing and able to complete follow-up.
• Transplant candidacy: Listed in the CLuTR registry and/or the local center's lung transplant waiting list, and scheduled to undergo allogeneic lung transplantation.
• Preoperative support status: Not on ongoing invasive mechanical ventilation preoperatively (endotracheal intubation or tracheostomy), and not receiving ECMO or other extracorporeal life support.
• Minimum key organ function requirements: LVEF ≥40%; eGFR ≥40 mL/min/1.73 m²; no acute liver failure and no evidence of decompensated cirrhosis/portal hypertension; ASA Physical Status (American Society of Anesthesiologists classification) ≤ IV.
• Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meeting the center's transplant requirements (e.g., undetectable viral load, noticeability per center policy).
• Rehabilitation potential and support: Demonstrates postoperative rehabilitation potential (able to cooperate with training) and has reliable caregiving support (at least one primary caregiver).

You may not qualify if:

• Informed consent/adherence: Refusal of or withdrawal of informed consent; investigator judgment that the participant cannot complete follow-up or has recurrent severe non-adherence.
• Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation.
• Recent major cardiovascular/cerebrovascular events: Acute coronary syndrome/myocardial infarction or stroke within the past 30 days.
• Severe organ dysfunction/acute failure: LVEF \<40%; eGFR \<40 mL/min/1.73 m²; acute liver failure or decompensated cirrhosis/portal hypertension; acute kidney failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorders or altered consciousness.
• High risk of severe infection: Septic shock; active extrapulmonary or disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting the center's transplant criteria).
• High bleeding risk: Severe bronchiectasis in which preoperative vascular intervention has not been performed or bleeding risk cannot be adequately mitigated.
• Malignancy: Active malignancy or malignancy associated with a high risk of recurrence or cancer-related mortality.
• Extreme body habitus: BMI ≥35 kg/m² or BMI \<16 kg/m²; or a confirmed diagnosis of severe chest wall deformity or spinal deformity.
• Substance use/dependence: Current use of cigarettes, e-cigarettes/vaping, smoked cannabis, or intravenous drug use.
• Tubeless/spontaneous-breathing strategy not safely feasible: The anesthesia team determines that a difficult airway is anticipated or that laryngeal mask airway (LMA)/non-intubated airway management is unsafe (e.g., expected intraoperative airway difficulty, pharyngeal/laryngeal stenosis unsuitable for LMA), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomical variation (e.g., anomalous right upper lobe bronchial takeoff in candidates for right lung transplantation) deemed difficult to manage safely with an LMA or single-lumen airway.
• Donor/donor-lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor-lung airway culture deemed unacceptable by the transplant team.
• Protected populations: Pregnant or breastfeeding women.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Central Study Contacts

Jiaqin Zhang, M.D.

CONTACT

+8613662833144; zhang_jqwow@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcome assessors (and statisticians, if applicable) will be blinded to intraoperative airway management and ventilation details.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor of Thoracic Surgery

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 3, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning at study completion and ending 2 years after study completion.
• Access Criteria: De-identified IPD and supporting documents (study protocol, statistical analysis plan, and data dictionary) will be available to qualified researchers outside the primary study group for scientifically sound research purposes. Access will be granted upon submission of a written request that includes a brief research proposal, analysis plan, and proof of relevant ethics/IRB review if applicable. Requests will be reviewed by the study steering committee/data access committee. Approved requestors must sign a data use agreement prohibiting re-identification attempts and onward sharing, and requiring appropriate data security measures and acknowledgement of the original study. Data will be provided through a secure electronic transfer or a controlled-access online repository; access instructions will be provided after approval.