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

NCT07384533 | Not Yet Recruiting

• 1 other identifier: BREATH-Rescue
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

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). Time Frame: From post-anesthesia care/ICU admission (immediately after leaving the operating room) through hospital discharge or in-hospital death (index hospitalization)

  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

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age and informed consent: Age ≥18 years. The participant or their legally authorized representative (LAR) is able to complete the informed consent process in a rescue/emergent transplant setting and sign written informed consent.
• Transplant candidacy: Listed in the China Lung Transplantation Registry (CLuTR) or the lung transplant waiting list of the participating center, with a planned allogeneic lung transplantation.
• Rescue/bridge definition (core cohort criterion): Meets any of the following conditions and is deemed by the study team to require rescue/emergent transplantation and to proceed to transplant: continuous invasive mechanical ventilation preoperatively (endotracheal intubation or tracheostomy); or preoperative extracorporeal membrane oxygenation (ECMO) / other extracorporeal life support (ECLS); or urgent escalation of support due to progressive respiratory and/or circulatory failure, entering a rescue transplant pathway.
• Minimum key organ function: Left ventricular ejection fraction (LVEF) ≥40%; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; American Society of Anesthesiologists (ASA) Physical Status classification ≤ IV.
• Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV meet the center's transplant requirements (e.g., undetectable viral load, as applicable).
• Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to cooperate with training) and 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 follow-up cannot be completed or that there is repeated serious 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 renal failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorder or impaired consciousness.
• High risk of severe infection: Septic shock; active extrapulmonary/disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting the center's transplant criteria).
• High risk of major bleeding: Severe bronchiectasis not treated with preoperative vascular intervention or not readily correctable.
• Malignancy: Active malignancy or malignancy with high risk of recurrence or cancer-related mortality.
• Severe chest wall or spinal deformity: Deemed by the study team to compromise surgical exposure, ventilation/airway management, or perioperative safety.
• Substance use/dependence: Current smoking, e-cigarette/vaping use, inhaled cannabis use, or intravenous drug use.
• Tubeless/breathing-preserved strategy not safely feasible: The anesthesia team judges a difficult airway or laryngeal mask/non-intubated airway management to be unsafe (e.g., anticipated difficult airway, pharyngeal/laryngeal stenosis unsuitable for laryngeal mask, or other conditions unfavorable for airway management), 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 origin in a planned right lung transplantation) such that safe management with a laryngeal mask or single-lumen tube is deemed unlikely.
• Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology that the transplant team deems unacceptable.
• Protected population: 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
• 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: January 21, 2026
• First Posted: February 3, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 30, 2028
• 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.