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Clinical Trials in China / NCT07362797
Recruiting Not applicable

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

NCT07362797 · tracked via the Priya Life Science China tracker
Sponsor
Diansan Su
Phase
Not applicable
Started
2026-05-30
Last updated
2026-08-17

Condition(s) studied

Thoracoscopic SurgeryDouble Lumen Tube IntubationOne-Lung Ventilation

Investigational drug(s) / intervention(s)

Video-guided right-sided double-lumen tubeConventional right-sided double-lumen tube

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.

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
\*\*Inclusion Criteria:\*\* 1. Adults aged 18 years or older. 2. American Society of Anesthesiologists physical status I-III. 3. Scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. 4. Able to provide written informed consent. \*\*Exclusion Criteria:\*\* 1. Contraindication to placement of a right-sided double-lumen tube, including a lesion involving the right main bronchus that precludes its use. 2. Known tracheobronchial anatomical abnormality that may interfere with right-sided double-lumen tube placement or lung isolation. 3. Known or anticipated difficult airway. 4. Requirement for rapid-sequence induction. 5. Emergency surgery. 6. Severe respiratory instability that, in the investigator's judgement, makes participation unsafe. 7. Concurrent participation in another interventional clinical trial that could interfere with the present study.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou Zhejiang Recruiting
Affiliated Hospital of Jiaxing University(The First Hospital of Jiaxing) Jiaxing Zhejiang Recruiting
The Second Affiliated Hospital of Jiaxing University(The Second Hospital of Jiaxing) Jiaxing Zhejiang Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07362797 on ClinicalTrials.gov ↗ ← All trials in China