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NCT Number: NCT07065565

Tubeless Tracheal and Carinal Reconstruction

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Guangzhou Medical University

Guangdong, Gaungzhou, 510120, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

non-intubated tracheal and carinal reconstruction

Procedure

non-intubated tracheal and carinal reconstruction

intubated tracheal and carinal reconstruction

Procedure

intubated tracheal and carinal reconstruction

Primary outcomes

  1. Conversion rate

    Time frame: postoperative in-hospital stay up to 30 days

    The rate of conversion to intubated approach in the operation

  2. Postoperative complications rate

    Time frame: postoperative in-hospital stay up to 30 days

    Number and severity of adverse events that are related to the treatment of each patient. Postoperative treatment-related complications were assessed by the Clavien-Dindo Classification. Treatment-related adverse events as assessed by CTCAE v5.0.

Secondary outcomes

  1. Operative time

    Time frame: postoperative in-hospital stay up to 30 days

    Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).

  2. Length of stay (LOS)

    Time frame: postoperative in-hospital stay up to 30 days

    Length of stay is the duration for enrolled patients until the date of meeting the criteria of hospital discharge since the date of surgery.

  3. Postoperative ICU stay

    Time frame: postoperative in-hospital stay up to 30 days

    Postoperative hospital stay is the duration for each patients until the date of meeting the criteria of ICU discharge since the date of surgery.

  4. Intraoperative bleeding loss

    Time frame: postoperative in-hospital stay up to 30 days

    blood loss in the operation

  5. Length of resection

    Time frame: postoperative in-hospital stay up to 30 days

    Length of resection in the operation

  6. Reconstruction time

    Time frame: postoperative in-hospital stay up to 30 days

    Reconstruction time was defined as the time between the start of resection (tracheal) and the finish of reconstruction (tracheal).

  7. Volume of postoperative drainage

    Time frame: postoperative in-hospital stay up to 30 days

    The volume of postoperative drainage of the patient was the sum of his daily drainage volume after the surgery.

  8. 1-year disease-free survival (DFS)

    Time frame: 1 year after surgery

    DFS at 1 year after surgery

  9. 1-year overall survival(OS)

    Time frame: 1 year after surgery

    OS after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Shuben Li

CONTACT

[email protected]

86+(020) 8306 2114

Sponsors and collaborators

Lead sponsor

Shuben Li

Other

Registry information

Official study title

Non-intubated vs Intubated Anesthesia for Tracheal and Carinal Reconstruction

Acronym: NOVA-01

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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