Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiansan Su
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Video-guided right-sided double-lumen tube
DeviceA 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
DeviceA 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.
Treatment groups
566 Participants
are divided into 2 treatment groupsGroup A: Video-guided right-sided double-lumen tubeExperimental treatment 1 intervention
Group B: Conventional right-sided double-lumen tubeActive comparator 1 intervention
Trial outcomes
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.
Time frame
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
1
Incidence of right upper-lobe bronchial obstruction
Right upper-lobe bronchial obstruction is defined as partial or complete obstruction of the right upper-lobe bronchial opening by the bronchial lumen or bronchial cuff after initial tube positioning, as confirmed by fibreoptic bronchoscopy. The outcome will be recorded as present or absent.
Time frame
After initial tube positioning and before initiation of one-lung ventilation (approximately 10 minutes).2
Incidence of intraoperative double-lumen tube displacement
Tube displacement is defined as any intraoperative displacement of the double-lumen tube that requires repositioning to restore satisfactory tube position, ventilation, or lung isolation. The outcome will be recorded as present or absent.
Time frame
From initiation of one-lung ventilation until completion of one-lung ventilation.3
Incidence of hypoxemia during one-lung ventilation
Hypoxemia is defined as peripheral oxygen saturation (SpO₂) \<90% during one-lung ventilation. The outcome will be recorded as present or absent.
Time frame
During one-lung ventilation.4
Requirement for rescue fibreoptic bronchoscopy
Rescue fibreoptic bronchoscopy is defined as fibreoptic bronchoscopy performed after initial tube positioning because of suspected tube malposition, inadequate lung isolation, ventilation abnormality, or need for tube repositioning. The outcome will be recorded as present or absent.
Time frame
From completion of initial tube positioning until completion of one-lung ventilation.Sponsors and contacts
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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
Source ClinicalTrials.gov