Tubeless (non-intubated) tracheal and carinal reconstruction

Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction

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

• Phase: NA
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (other)
• Locations: 1 site (Guangdong, Gaungzhou)
• Trial ID: NCT07065565 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Guangdong, Gaungzhou

• the First Affiliated Hospital of Guangzhou Medical University — Guangdong, Gaungzhou, China (RECRUITING)

Study contacts

• Study coordinator: Shuben Li

Conditions: Tracheal Disease, Airway Disease, non-intubated anesthesia, airway disease, tracheal reconstruction, carinal reconstruction