About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Video-guided right-sided double-lumen tube
- Conventional right-sided double-lumen tube
Treatment groups
Sponsors and collaborators
Diansan Su
Lead sponsor
Zhejiang University
Sponsor institution
First Affiliated Hospital of Zhejiang University
Collaborator
The Second Affiliated Hospital of Jiaxing University
Collaborator
Affiliated Hospital of Jiaxing University
Collaborator