NCT07065565

Tubeless Tracheal and Carinal Reconstruction

Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Shuben Li · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In recent year, non-intubated anesthesia had emerged as an available alternative for thoracic procedure. Whether non-intubated tracheal/carinal reconstruction confers distinct perioperative advantages over the conventional intubated approach remains uncertain. The purpose of this study was to evaluate the safety and perioperative outcomes of non-intubated versus intubated approaches in tracheal and carinal reconstruction.

Detailed description

Tracheal/carinal resection and reconstruction remains a technically demanding procedure with high risks of morbidity and mortality. Traditionally, tracheal surgery is performed under intubated anesthesia, with intermittent endotracheal ventilation to maintain oxygenation during airway reconstruction. However, endotracheal intubation with cross-field ventilation obstructs the surgical field and potentially complicating the reconstruction procedure. Non-intubated anesthesia have has gained widespread adoption for modern thoracic surgery. However, the safety and feasibility of non-intubated tracheal and carinal reconstruction have not been studied by randomized controlled trial. So, this randomized controlled trial aims to evaluate whether the non-intubated approach offers comparable short-term and long-term outcomes to the conventional intubated procedure.

Conditions

• Tracheal Disease
• Airway Disease

Interventions

Type	Name	Description
PROCEDURE	non-intubated tracheal and carinal reconstruction	non-intubated tracheal and carinal reconstruction
PROCEDURE	intubated tracheal and carinal reconstruction	intubated tracheal and carinal reconstruction

Timeline

• Start date: 2025-03-26
• Primary completion: 2028-05-01
• Completion: 2028-08-31
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China