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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: 3D Airway Reconstruction GroupExperimental treatment 1 intervention
Group B: Clinical Experience GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
Perioperative

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

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

Time frame
Perioperative
4

Surgeon satisfaction with lung collapse

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".

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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