End-stage Lung DiseaseNCT07384572
Perioperative Recovery Outcomes With a Spontaneous Breathing Strategy in Severely Underweight Lung Transplant Recipients
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 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). 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
- 56 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2026to 30 Jan 2029
- 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: 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).
[2] Exclusion Criteria
- 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.
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: Evaluation of Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Severely Underweight Lung Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study
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.
Read the detailed description
This prospective, multicenter, single-arm clinical study will evaluate the clinical effectiveness and safety of a spontaneous breathing-preserving anesthesia-surgical strategy, integrated with standardized nutritional optimization and a structured prehabilitation program, in lung transplant recipients with very low body weight (body mass index [BMI] <16 kg/m²). The overall purpose is to determine whether this bundled perioperative approach can enhance early postoperative recovery while maintaining acceptable perioperative survival in this high-risk population.
Eligible participants will be enrolled consecutively across participating centers and managed according to a standardized perioperative pathway. The intervention bundle includes: (1) preoperative nutritional optimization and prehabilitation tailored to severe low BMI status, and (2) an intraoperative anesthesia-surgical management strategy designed to preserve spontaneous breathing whenever clinically appropriate, with predefined criteria for escalation/conversion to endotracheal intubation and invasive mechanical ventilation (IMV) if safety thresholds are exceeded. Postoperatively, participants will receive standard monitoring and supportive care per institutional lung transplant practice, with protocolized collection of key respiratory support events and perioperative complications. Outcomes will be assessed during the index hospitalization and, where specified by the protocol, through a defined perioperative follow-up window (e.g., up to 30 days after surgery).
The primary clinical outcomes focus on early recovery and perioperative survival: (1) the proportion of participants requiring postoperative IMV, (2) postoperative length of hospital stay, and (3) perioperative survival within the protocol-defined time window (e.g., through hospital discharge and/or up to 30 days). Additional safety and recovery measures may include intensive care unit length of stay, re-intubation or tracheostomy, new or escalated extracorporeal support, primary graft dysfunction grading at prespecified time points, infections, airway complications, bleeding requiring re-intervention, acute kidney injury and renal replacement therapy, major cardiovascular/cerebrovascular events, and rejection episodes. Analyses will primarily be descriptive and estimation-focused, reporting event rates, central tendencies for length-of-stay outcomes, and survival estimates with confidence intervals; where appropriate, findings may be contextualized against prespecified benchmarks or contemporaneous historical outcomes.
The study is expected to generate high-quality prospective evidence on the feasibility and clinical signals of benefit of a spontaneous breathing-preserving perioperative strategy in severely underweight lung transplant recipients. It is hypothesized that the bundled approach will be associated with a lower need for postoperative IMV and shorter postoperative hospitalization, while maintaining acceptable perioperative survival and safety profiles in this vulnerable population. Results are intended to inform standardized perioperative pathways and support broader implementation and future comparative studies.
- Conditions
- End-stage Lung Disease
- Being tested
- Lung transplantation that preserves spontaneous breathing function
- Keywords
- Lung transplantation, Enhanced Recovery After Surgery, Severely Underweight
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 | 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 (or 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 start13 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jan 2029 (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
- 56 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
- NCT07384572
- Sponsor's protocol ID
- BREATHE-LowWt
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- 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
- Evaluation of Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Severely Underweight Lung Transplantation: A Prospective, Multicenter, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07384572
- Acronym / sponsor ID
- BREATHE-LowWt
- Conditions
- End-stage Lung Disease
- Keywords
- Lung transplantation, Enhanced Recovery After Surgery, Severely Underweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 13 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (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 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.
Detailed description
This prospective, multicenter, single-arm clinical study will evaluate the clinical effectiveness and safety of a spontaneous breathing-preserving anesthesia-surgical strategy, integrated with standardized nutritional optimization and a structured prehabilitation program, in lung transplant recipients with very low body weight (body mass index [BMI] <16 kg/m²). The overall purpose is to determine whether this bundled perioperative approach can enhance early postoperative recovery while maintaining acceptable perioperative survival in this high-risk population.
Eligible participants will be enrolled consecutively across participating centers and managed according to a standardized perioperative pathway. The intervention bundle includes: (1) preoperative nutritional optimization and prehabilitation tailored to severe low BMI status, and (2) an intraoperative anesthesia-surgical management strategy designed to preserve spontaneous breathing whenever clinically appropriate, with predefined criteria for escalation/conversion to endotracheal intubation and invasive mechanical ventilation (IMV) if safety thresholds are exceeded. Postoperatively, participants will receive standard monitoring and supportive care per institutional lung transplant practice, with protocolized collection of key respiratory support events and perioperative complications. Outcomes will be assessed during the index hospitalization and, where specified by the protocol, through a defined perioperative follow-up window (e.g., up to 30 days after surgery).
The primary clinical outcomes focus on early recovery and perioperative survival: (1) the proportion of participants requiring postoperative IMV, (2) postoperative length of hospital stay, and (3) perioperative survival within the protocol-defined time window (e.g., through hospital discharge and/or up to 30 days). Additional safety and recovery measures may include intensive care unit length of stay, re-intubation or tracheostomy, new or escalated extracorporeal support, primary graft dysfunction grading at prespecified time points, infections, airway complications, bleeding requiring re-intervention, acute kidney injury and renal replacement therapy, major cardiovascular/cerebrovascular events, and rejection episodes. Analyses will primarily be descriptive and estimation-focused, reporting event rates, central tendencies for length-of-stay outcomes, and survival estimates with confidence intervals; where appropriate, findings may be contextualized against prespecified benchmarks or contemporaneous historical outcomes.
The study is expected to generate high-quality prospective evidence on the feasibility and clinical signals of benefit of a spontaneous breathing-preserving perioperative strategy in severely underweight lung transplant recipients. It is hypothesized that the bundled approach will be associated with a lower need for postoperative IMV and shorter postoperative hospitalization, while maintaining acceptable perioperative survival and safety profiles in this vulnerable population. Results are intended to inform standardized perioperative pathways and support broader implementation and future comparative studies.
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 functionAll 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 (or 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.