NCT07065565

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Aug 2028

Study Start

First participant enrolled

March 26, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3.1 years

First QC Date

July 4, 2025

Last Update Submit

July 4, 2025

Conditions

Tracheal DiseaseAirway Disease

Keywords

non-intubated anesthesiaairway diseasetracheal reconstructioncarinal reconstruction

Outcome Measures

Primary Outcomes (2)

  • Conversion rate

    The rate of conversion to intubated approach in the operation

    postoperative in-hospital stay up to 30 days

  • Postoperative complications rate

    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.

    postoperative in-hospital stay up to 30 days

Secondary Outcomes (9)

  • Operative time

    postoperative in-hospital stay up to 30 days

  • Length of stay (LOS)

    postoperative in-hospital stay up to 30 days

  • Postoperative ICU stay

    postoperative in-hospital stay up to 30 days

  • Intraoperative bleeding loss

    postoperative in-hospital stay up to 30 days

  • Length of resection

    postoperative in-hospital stay up to 30 days

  • +4 more secondary outcomes

Study Arms (2)

Non-intubated group

EXPERIMENTAL

Surgical procedure: non-intubated tracheal and carinal reconstruction

Procedure: non-intubated tracheal and carinal reconstruction

Intubated group

ACTIVE COMPARATOR

Surgical procedure: intubated tracheal and carinal reconstruction

Procedure: intubated tracheal and carinal reconstruction

Interventions

non-intubated tracheal and carinal reconstructionPROCEDURE

non-intubated tracheal and carinal reconstruction

Non-intubated group
intubated tracheal and carinal reconstructionPROCEDURE

intubated tracheal and carinal reconstruction

Intubated group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Guangzhou Medical University

Guangdong, Gaungzhou, 510120, China

RECRUITING

MeSH Terms

Conditions

Tracheal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Shuben Li

CONTACT

86+(020) 8306 211413500030280@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

March 26, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)