Clinical trial · Interventional
A Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation
A Randomized Controlled Clinical Study on the Precise Positioning of Double-lumen Bronchial Intubation Guided by Medical Imaging-based Airway Three-dimensional Reconstruction Technology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation | Procedure | — | UNRESOLVED |
| Gender and Height-Based Double-Lumen Tube Selection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D Airway Reconstruction Group
- interventionNames
- Procedure: 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation
- type
- ACTIVE_COMPARATOR
- label
- Clinical Experience Group
- interventionNames
- Procedure: Gender and Height-Based Double-Lumen Tube Selection
Primary outcomes (1)
- measure
- Success rate of first intubation without the use of fiberoptic bronchoscope
- timeFrame
- Perioperative
- description
- The success rate of first intubation without using a fiberoptic bronchoscope is defined as follows: if no adjustment or only minor adjustment of less than 5mm is required after fiberoptic bronchoscopy, and any of the following criteria is met, it is considered unsuccessful: ① difficult insertion, requiring a change in the size of the double-lumen tube or other methods of pulmonary isolation; ② insertion into the opposite main bronchus; ③ bronchial cuff protruding into the carina (more than 50% of the cuff); ④ the edge of the bronchial cuff cuff is not visible at the entrance of the bronchus; ⑤ covering more than 50% of the opening of the right upper lung; ⑥ fiberoptic bronchoscopy cannot distinguish between tracheal/bronchial anatomical structures.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ②ASA physical status I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the informed consent form. Exclusion Criteria: * ① Preoperative presence of severe respiratory diseases, such as severe chronic obstructive pulmonary disease (COPD), pulmonary infection, and asthma exacerbation; ② Clinically assessed as a difficult airway, such as limited head tilt, spinal deformity, airway or head and neck masses, significant abnormalities in airway anatomy, etc.
References
Publications (0)
Data not yet available