New lung transplant method lets patients breathe naturally during surgery
NCT ID NCT07384507
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.
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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 60 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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Jan 2029
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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70 years and older
- 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.
\[1\] 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.
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As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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- Could keeping patients breathing naturally during lung transplant speed recovery?