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Breathing without a tube: new strategy aims to speed lung transplant recovery

NCT ID NCT07384546

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a spontaneous-breathing anesthesia strategy (using a laryngeal mask instead of a breathing tube) can help adults recover faster after lung transplant. About 110 participants in China will receive this 'tubeless' approach during surgery. Researchers will measure how many need a breathing tube after surgery, how long they stay in the hospital, and survival rates.

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 and surgical strategy (tubeless technique using laryngeal mask airway, minimized muscle relaxants, and nerve blocks)
What this could lead to
If it works, this could lead to faster recovery and shorter hospital stays after lung transplant by avoiding breathing tubes and sedation.
What could go wrong
This is an early single-arm study with no comparison group, so results may not be definitive. The strategy may not be safe for all patients, and emergency intubation may still be needed.

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

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

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: Aged 18-70 years; able to understand the study and provide written informed consent; willing and able to complete follow-up. 2. Transplant candidacy: Listed in the CLuTR registry and/or the local center's lung transplant waiting list, and scheduled to undergo allogeneic lung transplantation. 3. Preoperative support status: Not on ongoing invasive mechanical ventilation preoperatively (endotracheal intubation or tracheostomy), and not receiving ECMO or other extracorporeal life support. 4. 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. 5. 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). 6. 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 1. 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. 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 kidney failure requiring dialysis with low likelihood of recovery; significant preoperative neuropsychiatric disorders or altered consciousness. 5. 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). 6. High bleeding risk: Severe bronchiectasis in which preoperative vascular intervention has not been performed or bleeding risk cannot be adequately mitigated. 7. Malignancy: Active malignancy or malignancy associated with a high risk of recurrence or cancer-related mortality. 8. Extreme body habitus: BMI ≥35 kg/m² or BMI \<16 kg/m²; or a confirmed diagnosis of severe chest wall deformity or spinal deformity. 9. Substance use/dependence: Current use of cigarettes, e-cigarettes/vaping, smoked cannabis, or intravenous drug use. 10. 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. 11. Donor/donor-lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor-lung airway culture deemed unacceptable by the transplant team. 12. Protected populations: Pregnant or breastfeeding women.

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