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NCT Number: NCT07719959

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

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.

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Key information

Conditions

Pulmonary Nodules Lung Diseases Lung Neoplasms Multiple Pulmonary Nodules Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Qianmei Zhu, MD, PhD

CONTACT

[email protected]

86-18810651253

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Success rate of first intubation without the use of fiberoptic bronchoscope

    Time frame: Perioperative

    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.

Secondary outcomes

  1. Intubation duration

    Time frame: Perioperative

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

    Time frame: Perioperative

  3. Intraoperative airway pressure

    Time frame: Perioperative

    Airway peak pressure, plateau pressure, and compliance during supine dual lung ventilation and lateral single lung ventilation

  4. Surgeon satisfaction with lung collapse

    Time frame: Perioperative

    The surgeon satisfaction scale for lung collapse is a commonly used evaluation tool in clinical trials. The scale consists of 11 numbers from 0 to 10, representing varying degrees of satisfaction among surgeons regarding the effect of lung collapse. 0 indicates "very dissatisfied", and the satisfaction level increases progressively, with 10 indicating "very satisfied".

  5. Incidence of sore throat

    Time frame: Perioperative and day 1

  6. Incidence of hoarseness

    Time frame: Perioperative and day 1

  7. Incidence of hypoxemia

    Time frame: Perioperative

  8. DLT adjustment rate under fiberoptic bronchoscopy in lateral position

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

A Randomized Controlled Clinical Study on the Precise Positioning of Double-lumen Bronchial Intubation Guided by Medical Imaging-based Airway Three-dimensional Reconstruction Technology

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Sep 2, 2026

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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