A Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation

NCT07719959 | Not Yet Recruiting DMC

• 1 other identifier: K8513
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Pulmonary Nodules

Keywords

Thoracic Surgery; Anesthetic Management; Double-Lumen Tube Intubation; Chest CT; 3D Airway Reconstruction

Outcome Measures

Primary Outcomes (1)

• Success rate of first intubation without the use of fiberoptic bronchoscope

  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.

  Perioperative

Secondary Outcomes (7)

• Intubation duration

  Perioperative

• The incidence of switching to a different DLT size or adopting alternative intubation techniques

  Perioperative

• Intraoperative airway peak pressure

  Perioperative

• Surgeon satisfaction with lung collapse

  Perioperative

• Incidence of sore throat

  Perioperative and day 1

Study Arms (2)

3D Airway Reconstruction Group

EXPERIMENTAL

Procedure: 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation

Clinical Experience Group

ACTIVE COMPARATOR

Procedure: Gender and Height-Based Double-Lumen Tube Selection

Interventions

3D Airway Reconstruction-Guided Double-Lumen Tube Intubation PROCEDURE

Patients in this group will undergo preoperative chest CT scanning. The DICOM data will be imported into reconstruction software to create a 3D model of the trachea and bronchi. The diameter of the trachea, left and right main bronchus will be measured on the 3D model to select the appropriate size of the double-lumen tube (DLT). The 3D model can also provide suggestions on the depth of intubation and the bifurcation angle of the bronchus. During anesthesia induction, the selected DLT will be inserted based on the measurements derived from the 3D model.

3D Airway Reconstruction Group

Gender and Height-Based Double-Lumen Tube Selection PROCEDURE

Patients in this group will undergo DLT intubation guided by conventional clinical experience. The DLT size will be selected based on the patient's gender and height according to standard clinical formulas or empirical rules. No preoperative 3D airway reconstruction will be performed for tube sizing.

Clinical Experience Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Sex

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2025-09