Right-sided double-lumen tubes are used for lung isolation during thoracoscopic surgery but can be difficult to position because of right bronchial anatomy. This multicenter randomized controlled trial will compare a continuous video-guided right-sided double-lumen tube with a conventional right-sided double-lumen tube in adult patients undergoing thoracoscopic surgery requiring right-sided lung isolation. The primary objective is to determine whether continuous video guidance increases the rate of successful initial right-sided double-lumen tube positioning. Secondary outcomes include positioning time, clinically relevant intraoperative tube displacement, rescue fiberoptic bronchoscopy, lung collapse quality, hypoxemia during one-lung ventilation, and airway-related complications.
Adults aged 18 years or older.
American Society of Anesthesiologists (ASA) physical status I-III.
Patients scheduled for elective thoracoscopic surgery requiring lung isolation with a right-sided double-lumen tube.
Patients who provide written informed consent.
Contraindications to placement of a right-sided double-lumen tube, including right main bronchial lesions that preclude its use.
Known tracheobronchial anatomical abnormalities.
Known or anticipated difficult airway.
Requirement for rapid sequence induction.
Parallel
Continuous video-guided right-sided double-lumen tube
DeviceParticipants will receive a continuous video-guided right-sided double-lumen tube for lung isolation during thoracoscopic surgery. The device incorporates an integrated visualization system that provides continuous real-time airway visualization during tube positioning and intraoperative management.
Conventional right-sided double-lumen tube
DeviceParticipants will receive a conventional right-sided double-lumen tube for lung isolation during thoracoscopic surgery according to standard clinical practice.
Number of participants with successful initial right-sided double-lumen tube positioning assessed by fiberoptic bronchoscopy
Successful initial positioning is defined as Grade 1 (optimal) or Grade 2 (acceptable) tube position at the first protocol-mandated fiberoptic bronchoscopic assessment before any bronchoscopic adjustment. Grade 3 (malposition) is considered unsuccessful. Successful positioning requires an acceptable bronchial cuff position, adequate alignment of the right upper-lobe ventilation slot with the right upper-lobe bronchial orifice, absence of clinically relevant right upper-lobe obstruction, and a patent bronchus intermedius without the need for further advancement, withdrawal, or rotation of the tube. Each participant will be classified as successful or unsuccessful.
Time to initial right-sided double-lumen tube positioning
Time in seconds from passage of the double-lumen tube through the vocal cords into the trachea until the anesthesiologist completes the initial right-sided bronchial positioning and no further tube advancement, withdrawal, or rotation is performed before the protocol-mandated fiberoptic bronchoscopic assessment.
Number of unplanned intraoperative right-sided double-lumen tube repositioning events per participant
An event is defined as any unplanned advancement, withdrawal, rotation, or other repositioning of the right-sided double-lumen tube after satisfactory initial positioning has been confirmed. Minor positional changes not requiring intervention are not counted. For each repositioning event, the use of unplanned fiberoptic bronchoscopy for guidance or confirmation will be recorded as an event characteristic. The total number of repositioning events will be recorded for each participant.
Quality of surgical lung collapse assessed by a 3-point surgeon-rated scale
The operating surgeon will assess the quality of surgical lung collapse using a predefined 3-point ordinal scale: 1 = poor, lung collapse is insufficient and interferes with surgical exposure or requires additional intervention; 2 = moderate, lung collapse is partially adequate with some interference with surgical exposure but without the need for additional intervention; and 3 = good, lung collapse is adequate and does not interfere with surgical exposure. Higher scores indicate better lung collapse.
Number of hypoxemic episodes during one-lung ventilation per participant
A hypoxemic episode is defined as peripheral oxygen saturation (SpO₂) below 90% for at least 1 minute during one-lung ventilation, measured continuously by pulse oximetry. A new hypoxemic episode will be counted only after SpO₂ has recovered to 90% or above for at least 1 minute following the previous episode. The total number of hypoxemic episodes will be recorded for each participant.
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Diansan Su
Lead sponsor
Zhejiang University
Sponsor institution
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