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

NCT07362797 | Not Yet 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 has an integrated camera that provides continuous visual feedback during placement and surgery. Participants will be randomly assigned to receive one of the two tubes. The anaesthesiologist cannot be blinded because the devices are different, but participants will not be told which tube they receive. The study will compare successful initial tube placement, tube position, the need for repositioning or fibreoptic bronchoscopy, lung collapse and surgical exposure, airway management time, and airway-related complications. The results may help determine whether continuous visual guidance improves the safety and effectiveness of right-sided double-lumen tube management.

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 requires all of the following: successful first insertion; correct tube position; adequate lung isolation; acceptable surgical exposure; no withdrawal and reinsertion; and no tube exchange.

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

Secondary Outcomes (6)

• Right upper-lobe bronchial obstruction

  During initial tube positioning, before one-lung ventilation (approximately 10 minutes).

• Intraoperative tube displacement and repositioning

  From initiation of one-lung ventilation until the end of surgery (approximately 1-3 hours).

• Airway-related complications

  From tube insertion until 24 hours after surgery.

• Fibreoptic bronchoscopy utilisation

  From initial tube placement until the end of surgery (approximately 1-3 hours).

• Airway management time

  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 detection of tube displacement.

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

Conventional right-sided double-lumen tube

ACTIVE COMPARATOR

Participants undergo lung isolation for thoracoscopic surgery using a conventional right-sided double-lumen tube placed according to standard clinical technique and anatomical landmarks. Fibreoptic bronchoscopy is available when clinically indicated or according to predefined rescue criteria.

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. Position is assessed using standard clinical methods; fibreoptic bronchoscopy may be used when clinically indicated or as rescue.

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.

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 lung isolation with a right-sided double-lumen tube for one-lung ventilation.
• 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.
• Known or anticipated difficult airway.
• Requirement for rapid-sequence induction.
• Emergency surgery.
• Previous thoracic surgery within 4 weeks before enrolment.
• Active systemic infection or known/suspected pulmonary tuberculosis within 4 weeks before enrolment.
• Severe respiratory instability that, in the investigator's judgement, makes trial participation unsafe.
• Concurrent participation in another interventional clinical trial that could interfere with this 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

Location

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

Jiaxing, Zhejiang, 314000, China

Location

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

Jiaxing, Zhejiang, 314000, China

Location

Central Study Contacts

Heng Wen

CONTACT

+8615158080827; zyyywenheng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their allocated double-lumen tube. Because the devices have different visual and operational features, the anaesthesiologist performing intubation and other intraoperative clinical personnel cannot be blinded to treatment allocation. Allocation will not be disclosed to participants during the study unless clinically necessary.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)