Video Double-Lumen Tube for Secondary Pulmonary Resection

March 9, 2026 updated by: Diansan Su, Zhejiang University

Video Double-Lumen Tube for Secondary Pulmonary Resection: A Multicenter Randomized Controlled Trial

During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
      • Hangzhou, Zhejiang, China, 310000
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Yiwu, Zhejiang, China, 322000
        • The Fourth Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years.
  • History of previous pulmonary resection.
  • Scheduled for elective pulmonary surgery.
  • Planned to receive a left-sided double-lumen tube.
  • ASA physical status I-III.
  • Patients have signed the informed consent form.

Exclusion Criteria:

  • Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
  • Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
  • Uncontrolled asthma.
  • Confirmed pregnancy or current breastfeeding.
  • Multiple traumatic injuries.
  • Current participation in another clinical trial.
  • Other conditions deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video Double-Lumen Tube Group
Device: Video Double-Lumen Tube Group
Use the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position.
Active Comparator: Conventional Double-Lumen Tube
Device: Conventional Double-Lumen Tube Group
Insert a conventional left-sided double-lumen tube using standard intubation techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of first-attempt bronchial intubation
Time Frame: During the first intubation attempt
During the first intubation attempt

Secondary Outcome Measures

Outcome Measure
Time Frame
Intubation time
Time Frame: Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position
Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position
Requirement for and number of fiberoptic bronchoscopy uses
Time Frame: During the entire intraoperative period
During the entire intraoperative period
Frequency of intraoperative tube repositioning
Time Frame: During the entire intraoperative period
During the entire intraoperative period
Surgeon's rating of lung collapse quality
Time Frame: During the entire intraoperative period
During the entire intraoperative period
Incidence of difficult intubation
Time Frame: At the time of intubation
At the time of intubation
Intubation-related adverse events
Time Frame: From the start of intubation until 24 hours postoperatively
From the start of intubation until 24 hours postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of intraoperative hypoxemia
Time Frame: During the entire intraoperative period
During the entire intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 5, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2025B0593

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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