Tubeless Tracheal and Carinal Reconstruction (NOVA-01)

Shuben Li

Status: Enrolling

Conditions: Airway Disease; Tracheal Disease

Treatments: Procedure: non-intubated tracheal and carinal reconstruction; Procedure: intubated tracheal and carinal reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT07065565

ES-2025-075-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 2 patient groups

Non-intubated group

Experimental group

Description:

Surgical procedure: non-intubated tracheal and carinal reconstruction

Treatment:

Procedure: non-intubated tracheal and carinal reconstruction

Intubated group

Active Comparator group

Description:

Surgical procedure: intubated tracheal and carinal reconstruction

Treatment:

Procedure: intubated tracheal and carinal reconstruction