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

NCT07384507 | Not Yet Recruiting DMC

• 1 other identifier: BREATH-Elderly
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this prospective, multicenter, single-arm cohort study is to learn whether a lung transplantation approach that preserves patients' spontaneous breathing during surgery can improve early recovery in adults aged 70 years and older undergoing allogeneic lung transplantation. The main questions it aims to answer are whether, in adult lung transplant recipients aged 70 years and older, an anesthesia-surgical strategy designed to preserve spontaneous breathing is associated with better early postoperative recovery, specifically in terms of the need for postoperative invasive mechanical ventilation, postoperative length of hospital stay, and perioperative survival. Participants will undergo lung transplantation using a standardized anesthesia-surgical strategy intended to preserve spontaneous breathing, with predefined criteria for conversion to tracheal intubation and/or ECMO if clinically needed. They will receive standardized perioperative management and routine postoperative care (including ICU monitoring, rehabilitation, and recovery support) as determined by the transplant team. Participants will be assessed throughout hospitalization and followed for postoperative complications and outcomes through discharge and up to 30 days after surgery.

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

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: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age and informed consent: Age ≥70 years; able to understand the study and provide written informed consent, or, where permitted by ethics and applicable regulations, consent may be provided by a legally authorized representative (LAR)/authorized surrogate; willing and able to complete follow-up.
• Transplant candidacy: Listed in CLuTR or the lung transplant waiting list of the participating center, with a plan to undergo allogeneic lung transplantation.
• Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) preoperatively, and not receiving ECMO or other extracorporeal life support.
• Minimum key organ function: LVEF ≥40%; eGFR ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; ASA physical status ≤ IV (American Society of Anesthesiologists classification).
• Infection and communicable diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meets the center's transplant requirements (e.g., undetectable viral load, as 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:

• Informed consent/adherence: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or there is recurrent severe non-adherence.
• Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation.
• Recent major cardio-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 disorders or altered 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 bleeding risk: Severe bronchiectasis without preoperative vascular intervention or not correctable/mitigable.
• Malignancy: Active malignancy or tumors with high risk of recurrence or high cancer-related mortality risk.
• Extreme body habitus/major deformity: BMI ≥35 kg/m² or BMI \<16 kg/m²; clearly diagnosed severe chest wall deformity or spinal deformity.
• Substance use/dependence: Current use of cigarettes, e-cigarettes, smoked/vaped cannabis, or intravenous drug use.
• Tubeless/spontaneous-breathing strategy not safely feasible: Deemed by the anesthesia team to have a difficult airway or unsafe supraglottic/non-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal/laryngeal stenosis not suitable for a laryngeal mask), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomical variations (e.g., aberrant right upper lobe bronchial takeoff with planned right lung transplantation) where safe management with LMA/single-lumen approaches is judged unlikely.
• Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology considered 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 30, 2026
• Primary Completion (Estimated): December 1, 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.