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Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery: A Multicentre Randomized Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine,
RECRUITING
Hangzhou
Affiliated Hospital of Jiaxing University(The First Hospital of Jiaxing)
RECRUITING
Jiaxing
The Second Affiliated Hospital of Jiaxing University(The Second Hospital of Jiaxing)
NOT_YET_RECRUITING
Jiaxing
Contact Information
Primary
Heng Wen
zyyywenheng@zju.edu.cn
+8615158080827
Time Frame
Start Date: 2026-05-30
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 566
Treatments
Experimental: Video-guided right-sided double-lumen tube
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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Diansan Su
Collaborators: First Affiliated Hospital of Zhejiang University, The Second Affiliated Hospital of Jiaxing University, Affiliated Hospital of Jiaxing University

This content was sourced from clinicaltrials.gov