End-stage Lung DiseaseNCT07384533
Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Salvage 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 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Mar 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
[1] Inclusion Criteria
- 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).
[2] Exclusion Criteria
- 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.
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: Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Salvage Lung Transplantation: A Prospective Multicenter Single-Arm Clinical Study
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.
Read the detailed description
Purpose:
Rescue/bridge lung transplantation recipients represent a high-risk population with limited physiologic reserve and a high likelihood of prolonged postoperative support. This prospective, multicenter, single-arm clinical study (BREATH-Rescue) aims to evaluate the clinical effectiveness and perioperative safety of a breathing-preserved anesthesia-surgical strategy designed to minimize exposure to invasive mechanical ventilation while maintaining adequate gas exchange and hemodynamic stability. The study focuses on early postoperative recovery and perioperative survival, with primary outcomes centered on postoperative invasive mechanical ventilation (IMV) requirement, postoperative hospital length of stay (LOS), and perioperative survival through hospital discharge or 30 days after surgery (whichever occurs first).
Study Design and Methods:
BREATH-Rescue will enroll approximately 40 adult (≥18 years) rescue/bridge lung transplant candidates across multiple centers, with an anticipated ~36 participants contributing evaluable data for primary endpoint analyses. Rescue/bridge status is defined by meeting any of the following conditions prior to transplantation: ongoing invasive mechanical ventilation (endotracheal tube or tracheostomy), receipt of ECMO/other extracorporeal life support (ECLS), or urgent escalation of support due to progressive respiratory and/or circulatory failure prompting an emergency transplant pathway. Key baseline organ function thresholds are applied (e.g., LVEF ≥40%, eGFR ≥40 mL/min/1.73 m²), with exclusion of active uncontrolled infection.
All participants will undergo lung transplantation under a standardized breathing-preserved anesthesia-surgical pathway. The strategy emphasizes preservation or early restoration of spontaneous breathing when feasible, use of a laryngeal mask airway-based approach and intravenous anesthesia with multimodal analgesia/regional techniques, and continuous physiologic monitoring. Predefined criteria guide prompt conversion to endotracheal intubation and/or initiation or escalation of extracorporeal support when clinically necessary (e.g., inadequate oxygenation/ventilation, severe hypercapnia/acidosis, hemodynamic instability, major airway bleeding, insufficient operative exposure, or airway device failure). Postoperatively, participants will receive standardized perioperative management per center transplant pathways. Outcomes and safety events will be collected from screening through hospital discharge and up to 30 days after surgery, including key complications (e.g., primary graft dysfunction graded at 0/24/48/72 hours, respiratory support events such as re-intubation/tracheostomy/new or escalated ECMO, infections, bleeding requiring re-intervention, acute kidney injury, rejection episodes, and thrombotic events). The primary endpoint is a composite of three early recovery metrics (reported both as a composite and as individual components): postoperative IMV requirement, postoperative LOS, and perioperative survival.
Anticipated Results:
Investigators hypothesize that, in rescue/bridge lung transplant recipients, implementation of a breathing-preserved anesthesia-surgical strategy will increase the proportion of patients who do not require postoperative IMV, shorten postoperative hospital LOS, and achieve an acceptable perioperative survival rate through discharge or 30 days, compared with participating centers' historical outcomes under conventional intubated strategies. The study is expected to generate pragmatic, multicenter evidence on feasibility, safety signals (including conversion/intubation and ECMO escalation rates), and recovery trajectories in this high-risk population, thereby informing pathway standardization and the design of future controlled comparative studies.
- 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 | 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).
Time Frame: From post-anesthesia care/ICU admission (immediately after leaving the operating room) through hospital discharge or in-hospital death (index hospitalization)
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 start30 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion30 Mar 2028 (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
- 40 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
- NCT07384533
- Sponsor's protocol ID
- BREATH-Rescue
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- 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
- Perioperative Recovery Outcomes of a Spontaneous Breathing-Preserving Strategy in Salvage Lung Transplantation: A Prospective Multicenter Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07384533
- Acronym / sponsor ID
- BREATH-Rescue
- Conditions
- End-stage Lung Disease
- Keywords
- Lung transplantation, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 30 Mar 2028 (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 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.
Detailed description
Purpose:
Rescue/bridge lung transplantation recipients represent a high-risk population with limited physiologic reserve and a high likelihood of prolonged postoperative support. This prospective, multicenter, single-arm clinical study (BREATH-Rescue) aims to evaluate the clinical effectiveness and perioperative safety of a breathing-preserved anesthesia-surgical strategy designed to minimize exposure to invasive mechanical ventilation while maintaining adequate gas exchange and hemodynamic stability. The study focuses on early postoperative recovery and perioperative survival, with primary outcomes centered on postoperative invasive mechanical ventilation (IMV) requirement, postoperative hospital length of stay (LOS), and perioperative survival through hospital discharge or 30 days after surgery (whichever occurs first).
Study Design and Methods:
BREATH-Rescue will enroll approximately 40 adult (≥18 years) rescue/bridge lung transplant candidates across multiple centers, with an anticipated ~36 participants contributing evaluable data for primary endpoint analyses. Rescue/bridge status is defined by meeting any of the following conditions prior to transplantation: ongoing invasive mechanical ventilation (endotracheal tube or tracheostomy), receipt of ECMO/other extracorporeal life support (ECLS), or urgent escalation of support due to progressive respiratory and/or circulatory failure prompting an emergency transplant pathway. Key baseline organ function thresholds are applied (e.g., LVEF ≥40%, eGFR ≥40 mL/min/1.73 m²), with exclusion of active uncontrolled infection.
All participants will undergo lung transplantation under a standardized breathing-preserved anesthesia-surgical pathway. The strategy emphasizes preservation or early restoration of spontaneous breathing when feasible, use of a laryngeal mask airway-based approach and intravenous anesthesia with multimodal analgesia/regional techniques, and continuous physiologic monitoring. Predefined criteria guide prompt conversion to endotracheal intubation and/or initiation or escalation of extracorporeal support when clinically necessary (e.g., inadequate oxygenation/ventilation, severe hypercapnia/acidosis, hemodynamic instability, major airway bleeding, insufficient operative exposure, or airway device failure). Postoperatively, participants will receive standardized perioperative management per center transplant pathways. Outcomes and safety events will be collected from screening through hospital discharge and up to 30 days after surgery, including key complications (e.g., primary graft dysfunction graded at 0/24/48/72 hours, respiratory support events such as re-intubation/tracheostomy/new or escalated ECMO, infections, bleeding requiring re-intervention, acute kidney injury, rejection episodes, and thrombotic events). The primary endpoint is a composite of three early recovery metrics (reported both as a composite and as individual components): postoperative IMV requirement, postoperative LOS, and perioperative survival.
Anticipated Results:
Investigators hypothesize that, in rescue/bridge lung transplant recipients, implementation of a breathing-preserved anesthesia-surgical strategy will increase the proportion of patients who do not require postoperative IMV, shorten postoperative hospital LOS, and achieve an acceptable perioperative survival rate through discharge or 30 days, compared with participating centers' historical outcomes under conventional intubated strategies. The study is expected to generate pragmatic, multicenter evidence on feasibility, safety signals (including conversion/intubation and ECMO escalation rates), and recovery trajectories in this high-risk population, thereby informing pathway standardization and the design of future controlled 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
- 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). Time Frame: From post-anesthesia care/ICU admission (immediately after leaving the operating room) through hospital discharge or in-hospital death (index hospitalization)
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.