Tubeless (non-intubated) tracheal and carinal reconstruction
Official title: Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction
Run by The First Affiliated Hospital of Guangzhou Medical University · NCT07065565 · Data updated 2026-11-12
This study will test whether tubeless (non-intubated) tracheal and carinal reconstruction is as safe and gives better perioperative outcomes than conventional intubated surgery for adults with tracheal or airway disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 176 (estimated) |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangdong, Gaungzhou) |
| Status | Recruiting |
| Started | March 26, 2025 |
| Main results expected | May 1, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07065565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–80 years old with tracheal or airway disease confirmed by CT and bronchoscopy who are ASA class I–III and free of major uncontrolled comorbidities.
✕Probably not a fit
Patients with uncontrolled cardiac disease, severe systemic intercurrent illness, coagulation disorders, prior airway anatomical surgery, or other active malignancies are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–80 with tracheal or carinal disease confirmed by chest CT and bronchoscopy and who are ASA I–III are randomized to either non-intubated (tubeless) or conventional intubated anesthesia during tracheal/carinal resection and reconstruction. The trial compares perioperative safety, intraoperative technical factors, and short- and long-term clinical outcomes between the two anesthesia approaches. Key exclusion criteria include uncontrolled significant cardiac disease, severe systemic illness or infection, coagulation disorders, prior airway surgery producing anatomical abnormalities, and other active malignancy. All procedures and follow-up are conducted at the First Affiliated Hospital of Guangzhou Medical University using standardized surgical and anesthetic protocols.
Why it matters
Potential benefit: If successful, the tubeless approach could reduce obstruction of the surgical field, shorten operative time and recovery, and lower some perioperative complications.
How similar studies have gone: Non-intubated anesthesia has demonstrated feasibility and perioperative advantages in other thoracic surgeries, but randomized evidence specific to tracheal and carinal reconstruction is limited and this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Airway diseases were diagnosed by chest enhanced CT and bronchoscopy 2. The patients with age ≥ 18 and ≤ 80 years old 3. ASA (American Society of Anesthesiologists) stage: I-III 4. sign the informed consent. - Exclusion Criteria: 1. The patients have proved history of congestive heart failure, angina without good control with medicine; ECG-proved penetrating myocardial infarction; hypertension with bad control; valvulopathy with clinical significance; arrhythmia with high risk and out of control 2. The patients have severe systematic intercurrent disease, such as active infection or poorly controlled diabetes; coagulation disorders; hemorrhagic tendency or under treatment of thrombolysis or anticoagulant therapy 3. Airway anatomical abnormalities due to a history of surgery 4. Patients present with other malignancy
Where it's running
-
the First Affiliated Hospital of Guangzhou Medical University
Guangdong, Gaungzhou, China Recruiting
Study contacts
- Study coordinator: Shuben Li
- Email: 13500030280@163.com
- Phone: 86+(020) 8306 2114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.