ClinicalTrials.gg
RecruitingNCT07719959Updated Sep 2, 2026

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

An interventional study of 3D Airway Reconstruction-Guided Double-Lumen Tube Intubation and Gender and Height-Based Double-Lumen Tube Selection in Pulmonary Nodules, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Pulmonary Nodules

Keywords

  • Thoracic Surgery
  • Anesthetic Management
  • Double-Lumen Tube Intubation
  • Chest CT
  • 3D Airway Reconstruction
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In context

Multiple Pulmonary Nodules

99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.

This study's planned enrollment of 174 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ② I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the form.

Exclusion criteria

Exclusion Criteria:

  • ① Preoperative presence of severe respiratory diseases, such as severe (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
174 participants (estimated)

Study arms

  • Experimental
    3D Airway Reconstruction Group

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

  • Active comparator
    Clinical Experience Group

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

Interventions

  • Procedure3D 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 inserted based on the measurements derived from the 3D model.

  • ProcedureGender 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.

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What researchers measure

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

  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

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07719959
Responsible party
ZIJIA LIU (Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Jul 22, 2026
Start date
Aug 14, 2026
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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