End-stage Lung DiseaseBREATHE-LTxNCT07384546
BREATHE Study: Spontaneous Breathing-Preserved Anesthesia and Surgical Strategy for Hospital Recovery in Lung Transplantation
A study testing Lung transplantation that preserves spontaneous breathing function in people with End-stage Lung Disease, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- End-stage Lung Disease
- What is being tested?
- Lung transplantation that preserves spontaneous breathing function
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
【1】Inclusion Criteria
- 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).
【2】Exclusion Criteria
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Spontaneous Breathing-Preserved Anesthesia and Surgical Strategy to Improve Early Postoperative Hospital Recovery After Lung Transplantation (BREATHE), A Prospective, Multicenter, Blinded Endpoint Assessment Single-arm Clinical Study
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.
Read the detailed description
This is a prospective, multicenter, single-arm clinical study designed to evaluate a standardized perioperative pathway for adult lung transplantation that aims to preserve spontaneous breathing ("tubeless" strategy). The study will enroll approximately 110 participants across multiple hospitals in China. To reduce assessment bias in a single-arm design, key study endpoints will be evaluated by an independent team using prespecified definitions and adjudication rules.
The investigational perioperative pathway integrates anesthesia and surgical management with the goal of maintaining the participant's own breathing as much as possible during and after transplantation, while minimizing exposure to tracheal intubation, invasive mechanical ventilation (IMV), and deep sedation. The approach typically uses a laryngeal mask airway (LMA) for airway support, intravenous anesthesia with careful titration, and multimodal analgesia to achieve adequate comfort and cough control while allowing spontaneous respiration. Regional and/or local anesthetic techniques may be used to improve pain control and reduce airway stimulation. Intraoperative monitoring and ventilatory support are individualized, and lung recruitment or short periods of assisted ventilation may be used when clinically indicated.
Participant safety is prioritized throughout the procedure and postoperative period. The clinical team may convert to conventional tracheal intubation and IMV at any time if predefined clinical concerns arise, such as inadequate gas exchange, airway protection issues, hemodynamic instability, uncontrolled bleeding, or conditions that compromise surgical safety. Extracorporeal membrane oxygenation (ECMO) may be initiated or escalated when necessary according to institutional practice and prespecified clinical triggers. Postoperatively, participants receive standard transplant care per each center's routine protocols, including intensive monitoring and timely escalation of respiratory or circulatory support when required.
The study timeline includes a screening period prior to transplantation, comprehensive perioperative data capture, in-hospital follow-up through discharge, and structured follow-up after discharge to document early recovery and safety outcomes. Safety surveillance focuses on events occurring within 30 days after transplantation, and additional follow-up through 90 days captures short-term outcomes such as survival status and rehospitalization.
All study data are recorded in standardized case report forms and entered into a centralized database with built-in quality checks. The coordinating center oversees data completeness and consistency across sites, and the independent outcome review team adjudicates endpoints according to prespecified rules.
- Conditions
- End-stage Lung Disease
- Being tested
- Lung transplantation that preserves spontaneous breathing function
- Keywords
- Lung transplantation, Enhanced Recovery After Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung transplantation that preserves spontaneous breathing functionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lung transplantation that preserves spontaneous breathing function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: From start of transplant surgery through hospital discharge or postoperative Day 30, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start10 Jan 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Lung DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384546
- Sponsor's protocol ID
- BREATHE-LTx-Study
- Acronym
- BREATHE-LTx
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified individual participant data (IPD) underlying the analyses of this clinical study, limited to baseline and perioperative variables. Baseline IPD will include demographics (e.g., age, sex), primary diagnosis, key comorbidities, and transplant-relevant preoperative measures and donor/recipient characteristics recorded in structured fields. Perioperative IPD will include operative and anesthesia strategy, airway management, intraoperative/early postoperative respiratory and hemodynamic parameters, major perioperative interventions (e.g., ECMO use), and key in-hospital outcomes during the index hospitalization (e.g., need for postoperative IMV, complications, ICU/hospital length of stay, and in-hospital mortality). The study protocol and statistical analysis plan will also be shared. All direct identifiers will be removed and dates will be shifted/aggregated as needed to protect privacy.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Breathing-Preserved Anesthesia and Surgical Strategy to Improve Early Postoperative Hospital Recovery After Lung Transplantation (BREATHE), A Prospective, Multicenter, Blinded Endpoint Assessment Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT07384546
- Acronym / sponsor ID
- BREATHE-LTx / BREATHE-LTx-Study
- Conditions
- End-stage Lung Disease
- Keywords
- Lung transplantation, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multicenter, single-arm clinical study designed to evaluate a standardized perioperative pathway for adult lung transplantation that aims to preserve spontaneous breathing ("tubeless" strategy). The study will enroll approximately 110 participants across multiple hospitals in China. To reduce assessment bias in a single-arm design, key study endpoints will be evaluated by an independent team using prespecified definitions and adjudication rules.
The investigational perioperative pathway integrates anesthesia and surgical management with the goal of maintaining the participant's own breathing as much as possible during and after transplantation, while minimizing exposure to tracheal intubation, invasive mechanical ventilation (IMV), and deep sedation. The approach typically uses a laryngeal mask airway (LMA) for airway support, intravenous anesthesia with careful titration, and multimodal analgesia to achieve adequate comfort and cough control while allowing spontaneous respiration. Regional and/or local anesthetic techniques may be used to improve pain control and reduce airway stimulation. Intraoperative monitoring and ventilatory support are individualized, and lung recruitment or short periods of assisted ventilation may be used when clinically indicated.
Participant safety is prioritized throughout the procedure and postoperative period. The clinical team may convert to conventional tracheal intubation and IMV at any time if predefined clinical concerns arise, such as inadequate gas exchange, airway protection issues, hemodynamic instability, uncontrolled bleeding, or conditions that compromise surgical safety. Extracorporeal membrane oxygenation (ECMO) may be initiated or escalated when necessary according to institutional practice and prespecified clinical triggers. Postoperatively, participants receive standard transplant care per each center's routine protocols, including intensive monitoring and timely escalation of respiratory or circulatory support when required.
The study timeline includes a screening period prior to transplantation, comprehensive perioperative data capture, in-hospital follow-up through discharge, and structured follow-up after discharge to document early recovery and safety outcomes. Safety surveillance focuses on events occurring within 30 days after transplantation, and additional follow-up through 90 days captures short-term outcomes such as survival status and rehospitalization.
All study data are recorded in standardized case report forms and entered into a centralized database with built-in quality checks. The coordinating center oversees data completeness and consistency across sites, and the independent outcome review team adjudicates endpoints according to prespecified rules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tubeless LTx Group | Experimental | Procedure: Lung transplantation that preserves spontaneous breathing functionSingle-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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung transplantation that preserves spontaneous breathing functionThis 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. | Procedure or surgery | Tubeless LTx Group |
Primary outcome
Number of Participants Requiring Postoperative Invasive Mechanical Ventilation (IMV) During Index Hospitalization
Time frame: 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).
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).
Postoperative Hospital Length of Stay (Days) During Index Hospitalization
Time frame: From end of surgery (postoperative Day 0) until hospital discharge or in-hospital death (index hospitalization), assessed up to 90 days.
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.
Rate of Perioperative Survival
Time frame: From start of transplant surgery through hospital discharge or postoperative Day 30, whichever occurs first.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. We will share de-identified individual participant data (IPD) underlying the analyses of this clinical study, limited to baseline and perioperative variables. Baseline IPD will include demographics (e.g., age, sex), primary diagnosis, key comorbidities, and transplant-relevant preoperative measures and donor/recipient characteristics recorded in structured fields. Perioperative IPD will include operative and anesthesia strategy, airway management, intraoperative/early postoperative respiratory and hemodynamic parameters, major perioperative interventions (e.g., ECMO use), and key in-hospital outcomes during the index hospitalization (e.g., need for postoperative IMV, complications, ICU/hospital length of stay, and in-hospital mortality). The study protocol and statistical analysis plan will also be shared. All direct identifiers will be removed and dates will be shifted/aggregated as needed to protect privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lung transplantation that preserves spontaneous breathing function in people with End-stage Lung Disease, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaqin Zhang, M.D. (+8613662833144, zhang_jqwow@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Requiring Postoperative Invasive Mechanical Ventilation (IMV) During Index Hospitalization (time frame: 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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.