Could keeping patients breathing naturally during lung transplant speed recovery?
NCT ID NCT07384533
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new anesthesia method that lets patients breathe on their own during lung transplant surgery, instead of using a breathing tube. Researchers want to see if this approach helps patients recover faster and need less breathing support after surgery. The study will include 40 adults with end-stage lung disease who need a rescue transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- spontaneous-breathing-preserving anesthesia strategy during lung transplantation
- What this could lead to
- If successful, this approach could reduce the need for post-transplant breathing machines and shorten hospital stays, improving early recovery for critically ill lung transplant patients.
- What could go wrong
- This is a small, early-stage study with no control group, so results may not apply broadly. The procedure carries standard surgical risks like infection, bleeding, or graft failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\[1\] Inclusion Criteria 1. 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. 2. 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. 3. 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. 4. 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. 5. 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). 6. 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 1. 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. 2. Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation. 3. Recent major cardiovascular/cerebrovascular events: Acute coronary syndrome/myocardial infarction or stroke within the past 30 days. 4. 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. 5. 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). 6. High risk of major bleeding: Severe bronchiectasis not treated with preoperative vascular intervention or not readily correctable. 7. Malignancy: Active malignancy or malignancy with high risk of recurrence or cancer-related mortality. 8. Severe chest wall or spinal deformity: Deemed by the study team to compromise surgical exposure, ventilation/airway management, or perioperative safety. 9. Substance use/dependence: Current smoking, e-cigarette/vaping use, inhaled cannabis use, or intravenous drug use. 10. 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. 11. Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology that the transplant team deems unacceptable. 12. Protected population: Pregnant or breastfeeding women.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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