Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New lung transplant method lets patients breathe naturally during surgery

NCT ID NCT07384507

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 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.
Paused
Paused for now. It may or may not start again.
Ongoing
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 Results may not be published yet.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)

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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether keeping patients' natural breathing during lung transplant surgery helps them recover faster. It involves 60 adults aged 70 and older with end-stage lung disease. Instead of using a breathing tube and machine, doctors will use a mask and nerve blocks to let patients breathe on their own during the operation. The goal is to see if this reduces the need for breathing support after surgery and shortens hospital stays.

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 breathing machines after surgery and shorten hospital stays for older lung transplant patients.
What could go wrong
This is an early, single-arm study with only 60 participants, so results may not apply broadly. The procedure carries standard surgical risks, and preserving spontaneous breathing may not be feasible for all patients.

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 60 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 2029

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

70 years and older

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: Age ≥70 years; able to understand the study and provide written informed consent, or, where permitted by ethics and applicable regulations, consent may be provided by a legally authorized representative (LAR)/authorized surrogate; willing and able to complete follow-up. 2. Transplant candidacy: Listed in CLuTR or the lung transplant waiting list of the participating center, with a plan to undergo allogeneic lung transplantation. 3. Preoperative support status: Not receiving ongoing invasive mechanical ventilation (endotracheal intubation or tracheostomy) preoperatively, and not receiving ECMO or other extracorporeal life support. 4. Minimum key organ function: LVEF ≥40%; eGFR ≥40 mL/min/1.73 m²; no evidence of acute liver failure or decompensated cirrhosis/portal hypertension; ASA physical status ≤ IV (American Society of Anesthesiologists classification). 5. Infection and communicable diseases: No evidence of active infection; no active tuberculosis; HIV/HBV/HCV status meets the center's transplant requirements (e.g., undetectable viral load, as applicable). 6. Rehabilitation and support: Demonstrated potential for postoperative rehabilitation (able to participate in training) and reliable caregiving support (at least one primary caregiver). \[2\] Exclusion Criteria 1. Informed consent/adherence: Refusal or withdrawal of informed consent; investigator judgment that follow-up cannot be completed or there is recurrent severe non-adherence. 2. Transplant type: Re-transplantation, multi-organ transplantation, or planned lobar lung transplantation. 3. Recent major cardio-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 disorders or altered 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 bleeding risk: Severe bronchiectasis without preoperative vascular intervention or not correctable/mitigable. 7. Malignancy: Active malignancy or tumors with high risk of recurrence or high cancer-related mortality risk. 8. Extreme body habitus/major deformity: BMI ≥35 kg/m² or BMI \<16 kg/m²; clearly diagnosed severe chest wall deformity or spinal deformity. 9. Substance use/dependence: Current use of cigarettes, e-cigarettes, smoked/vaped cannabis, or intravenous drug use. 10. Tubeless/spontaneous-breathing strategy not safely feasible: Deemed by the anesthesia team to have a difficult airway or unsafe supraglottic/non-intubated airway management (e.g., anticipated intraoperative airway difficulty, pharyngeal/laryngeal stenosis not suitable for a laryngeal mask), including but not limited to: Mallampati class \>III, mouth opening \<3 cm, thyromental distance \<5 cm, or significant airway anatomical variations (e.g., aberrant right upper lobe bronchial takeoff with planned right lung transplantation) where safe management with LMA/single-lumen approaches is judged unlikely. 11. Donor/donor lung limitations: Donor age \>60 years; donor mechanical ventilation \>14 days; positive donor airway microbiology considered unacceptable by the transplant team. 12. Protected populations: Pregnant or breastfeeding women.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for End-stage lung disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.