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Not yet recruiting NCT07719959

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

No phase Interventional Pulmonary Nodules

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation, Gender and Height-Based Double-Lumen Tube Selection.
Who it may be relevant to
Registry conditions: Pulmonary Nodules. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • Procedure 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation
    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 in
  • Procedure Gender and Height-Based Double-Lumen Tube Selection
    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 outcome measures

  • Success rate of first intubation without the use of fiberoptic bronchoscope [Time frame: Perioperative]
Secondary outcome measures (7)
  • Intubation duration [Time frame: Perioperative]
  • The incidence of switching to a different DLT size or adopting alternative intubation techniques [Time frame: Perioperative]
  • Intraoperative airway peak pressure [Time frame: Perioperative]
  • Surgeon satisfaction with lung collapse [Time frame: Perioperative]
  • Incidence of sore throat [Time frame: Perioperative and day 1]
  • Incidence of hoarseness [Time frame: Perioperative and day 1]
  • Incidence of hypoxemia [Time frame: Perioperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07719959 · K8513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗