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No breathing tube needed: new lung transplant approach tested

NCT ID NCT07120230

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

30 people

The number who actually took part.

Started

Aug 2025

Finished

Jan 2026

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.

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

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510163, China

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