No breathing tube needed: new lung transplant approach tested
NCT ID NCT07120230
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new way to do lung transplants without the usual breathing tube. Instead, patients used a laryngeal mask and breathed on their own during surgery. The goal was to see if this approach is safe and helps patients recover faster. Thirty adults on the lung transplant list took part in this single-arm study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tubeless lung transplantation surgery (procedure using laryngeal mask airway and regional anesthesia)
- What this could lead to
- If successful, this could lead to faster recovery and shorter hospital stays for lung transplant patients by avoiding standard breathing tubes.
- What could go wrong
- This is a small, early study with only 30 patients and no comparison group, so results may not apply to all patients. Risks include breathing problems or need for emergency intubation.
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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30 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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Jan 2026
- 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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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 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.
Inclusion Criteria: 1. Subjects must voluntarily participate in this study, possess full civil capacity, be able to understand the study protocol, and sign a written informed consent. 2. Be between 18 and 74 years of age. 3. Be listed on the lung transplant waiting list of the China Lung Transplant Registry (CLuTR) or their respective centers and intend to undergo lung transplantation. 4. Have an American Society of Anesthesiologists (ASA) anesthesia grade 4 or lower and be expected to be able to tolerate anesthesia. 5. Preoperative assessment indicates that cardiac function (LVEF ≥ 50%), renal function (eGFR ≥ 60 mL/min/1.73 m²), and liver function (Child-Pugh A) are compatible with surgery. 6) Completed the pre-lung transplant respiratory rehabilitation program assessment and demonstrated good compliance; 7\) Not receiving continuous endotracheal intubation or tracheostomy prior to surgery; 8) No active infection, including active tuberculosis, HIV, or positive hepatitis B/C viral load before surgery; 9) Have a clear and reliable post-operative care support system (including at least one primary caregiver). Exclusion Criteria: 1. Refusing to sign informed consent or withdrawing informed consent during the trial; 2. Planning to undergo a second lung transplant or a combined multi-organ transplant (such as heart-lung, lung-liver, lung-kidney, etc.); 3. Clearly combined with uncontrollable active infection (such as tuberculosis, uncontrolled fungal infection) or sepsis; 4. Patients with obvious neuropsychiatric disorders, unconsciousness or long-term use of sedative/analgesic psychotropic drugs before surgery; 5. Active malignant tumors (except those treated within the past 2 years) or those with a high risk of postoperative recurrence; 6. Clearly diagnosed severe chest deformity or spinal deformity that may affect lung compliance during surgery; 7. Serum anti-HLA high sensitization (PRA ≥ 80%) and no matching donor available; 8. There are clear contraindications to the planned tubeless surgical anesthesia strategy (such as expected intraoperative airway difficulty, pharyngeal stenosis and laryngeal mask unsuitable, etc.); 9. Pregnant or lactating women. 10. Other conditions deemed unsuitable for participation in this study by the investigator (e.g., anticipated inability to complete follow-up, concurrent malignancy, etc.). 11. Patients with bronchiectasis or bronchial vascular hyperplasia difficult to manage with interventional therapy prior to surgery.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510163, China
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