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Recruiting NCT07065565

Tubeless Tracheal and Carinal Reconstruction

No phase Interventional Tracheal Disease Airway Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: non-intubated tracheal and carinal reconstruction, intubated tracheal and carinal reconstruction.
Who it may be relevant to
Registry conditions: Tracheal Disease, Airway Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction

Overview

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.

Interventions

  • Procedure non-intubated tracheal and carinal reconstruction
    non-intubated tracheal and carinal reconstruction
  • Procedure intubated tracheal and carinal reconstruction
    intubated tracheal and carinal reconstruction

Primary outcome measures

  • Conversion rate [Time frame: postoperative in-hospital stay up to 30 days]
  • Postoperative complications rate [Time frame: postoperative in-hospital stay up to 30 days]
Secondary outcome measures (9)
  • Operative time [Time frame: postoperative in-hospital stay up to 30 days]
  • Length of stay (LOS) [Time frame: postoperative in-hospital stay up to 30 days]
  • Postoperative ICU stay [Time frame: postoperative in-hospital stay up to 30 days]
  • Intraoperative bleeding loss [Time frame: postoperative in-hospital stay up to 30 days]
  • Length of resection [Time frame: postoperative in-hospital stay up to 30 days]
  • Reconstruction time [Time frame: postoperative in-hospital stay up to 30 days]
  • Volume of postoperative drainage [Time frame: postoperative in-hospital stay up to 30 days]
  • 1-year disease-free survival (DFS) [Time frame: 1 year after surgery]
  • 1-year overall survival(OS) [Time frame: 1 year after surgery]

Eligibility criteria

Inclusion criteria

  • Airway diseases were diagnosed by chest enhanced CT and bronchoscopy
  • The patients with age ≥ 18 and ≤ 80 years old
  • ASA (American Society of Anesthesiologists) stage: I-III
  • sign the informed consent. -

Exclusion criteria

  • 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
  • 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
  • Airway anatomical abnormalities due to a history of surgery
  • Patients present with other malignancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • the First Affiliated Hospital of Guangzhou Medical University — Guangdong

Identifiers

NCT: NCT07065565 · ES-2025-075-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗