Perioperative Recovery Outcomes With a Spontaneous Breathing Strategy in Severely Underweight Lung Transplant Recipients

NCT07384572 | Not Yet Recruiting DMC

• 1 other identifier: BREATHE-LowWt
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective, multicenter, single-arm clinical study is to learn whether a spontaneous breathing-preserving perioperative management strategy can improve recovery and is safe in lung transplant recipients with very low body weight (body mass index \[BMI\] \<16 kg/m²). The main questions it aims to answer are whether, in lung transplant recipients with very low body weight (BMI \<16 kg/m²), a spontaneous breathing-preserving anesthesia-surgical strategy combined with standardized nutritional optimization and a prehabilitation program can improve early postoperative recovery and perioperative survival. Specifically, the study will assess the proportion of participants who require postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival within the protocol-defined time window (e.g., through hospital discharge). Participants will undergo lung transplantation using a perioperative strategy that preserves spontaneous breathing whenever clinically appropriate, with predefined criteria for conversion to endotracheal intubation and mechanical ventilation if needed. They will receive standard postoperative monitoring and supportive care, with respiratory support events and perioperative complications assessed during the index hospitalization (and up to 30 days after surgery, if specified in the protocol). Key outcomes will be collected from routine clinical care, including postoperative ventilatory support status, length of hospital stay, and major safety events.

Conditions

End-stage Lung Disease

Keywords

Lung transplantation; Enhanced Recovery After Surgery; Severely Underweight

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 (or 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

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: Age ≥18 years; able to understand the study and provide written informed consent; willing and able to comply with follow-up.
• Transplant candidacy: Listed in CLuTR or the participating center's lung transplant waiting list and scheduled to undergo allogeneic lung transplantation.
• Low body weight definition (core cohort criterion): Preoperative BMI \<16 kg/m², calculated using the most recent traceable preoperative height and weight within the evaluation window.
• Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) and not on ECMO or other extracorporeal life support preoperatively.
• Minimum acceptable end-organ function: LVEF ≥40%; 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 ≤ IV.
• Infection and transmissible diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meeting center transplant requirements (e.g., undetectable viral load, where applicable).
• Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver).

You may not qualify if:

• Consent/compliance: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or presence of recurrent severe non-adherence.
• Transplant type: Retransplantation, 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 altered mental status.
• High-risk/severe infection: Septic shock; active extrapulmonary or disseminated infection; active tuberculosis; detectable HIV viral load (or otherwise not meeting center transplant standards).
• High bleeding risk: 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: Definitively diagnosed severe thoracic cage deformity or spinal deformity.
• Substance use/dependence: Current use of cigarettes, e-cigarettes, inhaled cannabis, or intravenous drugs.
• Tubeless/spontaneous breathing-preserving strategy not safely feasible: Determined by the anesthesia team to have a difficult airway or unsafe supraglottic/non-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal/laryngeal narrowing not suitable for a laryngeal mask airway), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomic variants (e.g., aberrant right upper lobe bronchial takeoff in a planned right lung transplant) deemed difficult to manage safely with an LMA or single-lumen tube.
• Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology 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
• 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 13, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 30, 2029
• 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.