Tubeless Tracheal and Carinal Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-26

Study Completion Date

2028-08-31

Brief Summary

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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.

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Detailed Description

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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

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Tracheal Disease Airway Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-intubated group

Surgical procedure: non-intubated tracheal and carinal reconstruction

Group Type EXPERIMENTAL

non-intubated tracheal and carinal reconstruction

Intervention Type PROCEDURE

non-intubated tracheal and carinal reconstruction

Intubated group

Surgical procedure: intubated tracheal and carinal reconstruction

Group Type ACTIVE_COMPARATOR

intubated tracheal and carinal reconstruction

Intervention Type PROCEDURE

intubated tracheal and carinal reconstruction

Interventions

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non-intubated tracheal and carinal reconstruction

Intervention Type PROCEDURE

intubated tracheal and carinal reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No