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

NCT07362797 | Recruiting

• 1 other identifier: ZJU2025C144
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Video-guided right-sided double-lumen tube; Right-sided double-lumen tube; One-lung ventilation; Fibreoptic bronchoscopy; Thoracoscopic surgery; Lung isolation

Outcome Measures

Primary Outcomes (1)

• Successful initial right-sided double-lumen tube placement

  Successful initial placement is defined as placement of the assigned right-sided double-lumen tube on the first intubation attempt, with satisfactory final tube position and satisfactory lung isolation, without withdrawal and reinsertion or exchange to another airway device before initiation of one-lung ventilation.

  From initial insertion of the assigned right-sided double-lumen tube until confirmation of satisfactory tube position before initiation of one-lung ventilation (approximately 10 minutes).

Secondary Outcomes (7)

• Incidence of right upper-lobe bronchial obstruction

  After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).

• Incidence of intraoperative double-lumen tube displacement

  From initiation of one-lung ventilation until completion of one-lung ventilation.

• Incidence of hypoxemia during one-lung ventilation

  During one-lung ventilation.

• Requirement for rescue fibreoptic bronchoscopy

  From completion of initial tube positioning until completion of one-lung ventilation.

• Time to satisfactory right-sided double-lumen tube positioning

  During initial tube placement after anaesthesia induction (approximately 10 minutes).

Study Arms (2)

Video-guided right-sided double-lumen tube

EXPERIMENTAL

Participants undergo lung isolation for thoracoscopic surgery using a video-guided right-sided double-lumen tube. The integrated camera provides continuous airway visualisation to facilitate initial positioning and intraoperative detection of tube displacement. Final tube position is confirmed by fibreoptic bronchoscopy after initial positioning. Subsequent fibreoptic bronchoscopy during one-lung ventilation is performed only when clinically indicated or according to predefined rescue criteria.

Device: Video-guided right-sided double-lumen tube

Conventional right-sided double-lumen tube

ACTIVE COMPARATOR

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.

Device: Conventional right-sided double-lumen tube

Interventions

Conventional right-sided double-lumen tube DEVICE

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.

Conventional right-sided double-lumen tube

Video-guided right-sided double-lumen tube DEVICE

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.

Video-guided right-sided double-lumen tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• American Society of Anesthesiologists physical status I-III.
• Scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube.
• Able to provide written informed consent.

You may not qualify if:

• Contraindication to placement of a right-sided double-lumen tube, including a lesion involving the right main bronchus that precludes its use.
• Known tracheobronchial anatomical abnormality that may interfere with right-sided double-lumen tube placement or lung isolation.
• Known or anticipated difficult airway.
• Requirement for rapid-sequence induction.
• Emergency surgery.
• Severe respiratory instability that, in the investigator's judgement, makes participation unsafe.
• Concurrent participation in another interventional clinical trial that could interfere with the present study.

Sponsors & Collaborators

• Diansan Su: lead
• Affiliated Hospital of Jiaxing University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator

Study Sites (3)

The First Affiliated Hospital, Zhejiang University School of Medicine,

Hangzhou, Zhejiang, 310000, China

RECRUITING

Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing）

Jiaxing, Zhejiang, 314000, China

RECRUITING

The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing）

Jiaxing, Zhejiang, 314000, China

NOT YET RECRUITING

Central Study Contacts

Heng Wen

CONTACT

+8615158080827; zyyywenheng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will remain blinded to treatment allocation. Because the video-guided and conventional right-sided double-lumen tubes have distinct visual and operational characteristics, the anaesthesiologist performing tracheal intubation and other intraoperative personnel directly involved in airway management cannot be blinded to group assignment. Outcome assessment will be performed by personnel who are not involved in the airway intervention and remain unaware of treatment allocation. Treatment allocation will not be disclosed to participants or blinded outcome assessors unless clinically necessary.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Model Details: Multicentre, randomized, parallel-group controlled trial with 1:1 allocation to video-guided right-sided double-lumen tube placement or conventional right-sided double-lumen tube placement.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)