Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery

NCT07362797 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2026-08-17

No results posted yet for this study

Summary

This multicentre randomised controlled trial compares a video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adults undergoing elective thoracoscopic surgery requiring one-lung ventilation. The video-guided tube incorporates an integrated camera that provides continuous airway visualisation during initial placement and intraoperative monitoring.

Participants will be randomly assigned in a 1:1 ratio to receive one of the two tubes. Final tube position after initial placement will be confirmed by fibreoptic bronchoscopy in both groups. During one-lung ventilation, additional fibreoptic bronchoscopy will be performed only when clinically indicated or according to predefined rescue criteria.

The primary outcome is successful initial right-sided double-lumen tube placement. Secondary outcomes include right upper-lobe bronchial obstruction, intraoperative tube displacement, hypoxemia during one-lung ventilation, requirement for rescue fibreoptic bronchoscopy, time to satisfactory tube positioning, quality of operative lung collapse, and the number of intraoperative tube repositioning events.

Participants and outcome assessors will remain blinded to treatment allocation, whereas the anaesthesiologist performing intubation cannot be blinded because of the distinct visual and operational characteristics of the two devices. The study aims to determine whether continuous airway visualisation improves the effectiveness and stability of right-sided double-lumen tube management during thoracoscopic surgery.

Conditions

  • Thoracoscopic Surgery
  • Double Lumen Tube Intubation
  • One-Lung Ventilation

Interventions

DEVICE

Video-guided right-sided double-lumen tube

A right-sided double-lumen tube with an integrated visualisation system that provides continuous airway visual feedback during placement and intraoperative monitoring. Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.

DEVICE

Conventional right-sided double-lumen tube

A conventional right-sided double-lumen tube used for lung isolation. Initial placement is performed using standard clinical techniques and anatomical landmarks. Fibreoptic bronchoscopy is used to confirm final tube position after initial positioning and remains available as a rescue technique when clinically indicated.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER
  • The Second Affiliated Hospital of Jiaxing University

    collaborator OTHER
  • Affiliated Hospital of Jiaxing University

    collaborator OTHER
  • Diansan Su

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2026-12-24
Completion
2027-03-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362797 on ClinicalTrials.gov