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Not yet recruiting NCT07467005

Video Double-Lumen Tube for Secondary Pulmonary Resection

No phase Interventional Lung Cancer Pulmonary Nodule

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: Video Double-Lumen Tube Group, Conventional Double-Lumen Tube Group.
Who it may be relevant to
Registry conditions: Lung Cancer, Pulmonary Nodule. Basic parameters: from 18 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
China
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

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

Overview

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.

Interventions

  • 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.
  • Device Conventional Double-Lumen Tube Group
    Insert a conventional left-sided double-lumen tube using standard intubation techniques.

Primary outcome measures

  • Success rate of first-attempt bronchial intubation [Time frame: During the first intubation attempt]
Secondary outcome measures (6)
  • Intubation time [Time frame: 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]
  • Frequency of intraoperative tube repositioning [Time frame: During the entire intraoperative period]
  • Surgeon's rating of lung collapse quality [Time frame: During the entire intraoperative period]
  • Incidence of difficult intubation [Time frame: At the time of intubation]
  • Intubation-related adverse events [Time frame: From the start of intubation until 24 hours postoperatively]

Eligibility criteria

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.

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
Single blind
Primary purpose
Prevention

Study locations

China · 3 centers
  • The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Zhejiang Cancer hospital — Hangzhou
  • The Fourth Affiliated Hospital, Zhejiang University School of Medicine — Yiwu

Identifiers

NCT: NCT07467005 · ZJU2025B0593

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗