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.
NCT Number: NCT07362797
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 has an integrated camera that provides continuous visual feedback during placement and surgery.
Participants will be randomly assigned to receive one of the two tubes. The anaesthesiologist cannot be blinded because the devices are different, but participants will not be told which tube they receive. The study will compare successful initial tube placement, tube position, the need for repositioning or fibreoptic bronchoscopy, lung collapse and surgical exposure, airway management time, and airway-related complications. The results may help determine whether continuous visual guidance improves the safety and effectiveness of right-sided double-lumen tube management.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The First Affiliated Hospital, Zhejiang University School of Medicine,, Hangzhou, Zhejiang, China
Right-sided double-lumen tubes are used to achieve lung isolation and one-lung ventilation during thoracoscopic surgery. Correct positioning is important for adequate ventilation, lung collapse, and surgical exposure. However, placement of a conventional right-sided double-lumen tube can be challenging because of the short right main bronchus and the need to align the ventilation slot with the right upper-lobe bronchial opening. Tube displacement during positioning or surgery may require repositioning or fibreoptic bronchoscopy.
This prospective, multicentre, parallel-group randomised controlled superiority trial will enrol 566 adult participants scheduled for elective thoracoscopic surgery requiring one-lung ventilation with a right-sided double-lumen tube. Participants will be allocated in a 1:1 ratio to receive either a video-guided right-sided double-lumen tube or a conventional right-sided double-lumen tube. The video-guided device incorporates an integrated visualisation system that provides continuous airway visual feedback during initial placement and intraoperative monitoring. In the conventional group, tube placement and position assessment will follow standard clinical practice; fibreoptic bronchoscopy may be used when clinically indicated or as rescue.
The primary outcome is successful initial right-sided double-lumen tube placement. Successful placement requires successful first insertion, correct tube position, adequate lung isolation, acceptable surgical exposure, no withdrawal and reinsertion, and no tube exchange. Secondary outcomes include right upper-lobe bronchial obstruction; intraoperative tube displacement and repositioning; fibreoptic bronchoscopy utilisation; airway management time; lung collapse and surgical exposure quality; and airway-related complications through 24 hours after surgery.
Participants will be unaware of their allocated tube. Because of the distinct visual and operational features of the devices, the anaesthesiologist performing intubation and other intraoperative clinical personnel cannot be blinded. Outcome data will be collected according to the prespecified protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A right-sided double-lumen tube with an integrated visualisation system that provides continuous airway visual feedback during placement and intraoperative monitoring.
A conventional right-sided double-lumen tube used for lung isolation. Position is assessed using standard clinical methods; fibreoptic bronchoscopy may be used when clinically indicated or as rescue.
Time frame: From initial right-sided double-lumen tube insertion after anaesthesia induction until confirmation of satisfactory tube position before one-lung ventilation (approximately 10 minutes).
Successful initial placement requires all of the following: successful first insertion; correct tube position; adequate lung isolation; acceptable surgical exposure; no withdrawal and reinsertion; and no tube exchange.
Time frame: During initial tube positioning, before one-lung ventilation (approximately 10 minutes).
Visibility and alignment of the right upper-lobe bronchial opening, classified as completely visible (optimal), partially visible (acceptable), or not visible (incorrect).
Time frame: From initiation of one-lung ventilation until the end of surgery (approximately 1-3 hours).
Number of tube displacements and repositioning events during one-lung ventilation. A movement requiring adjustment of more than 0.5 cm is recorded as tube displacement; adjustment time is also recorded.
Time frame: From tube insertion until 24 hours after surgery.
Occurrence of hypoxaemia, high airway pressure, air leak, airway injury or bleeding, sore throat, and hoarseness.
Time frame: From initial tube placement until the end of surgery (approximately 1-3 hours).
Any use of fibreoptic bronchoscopy, including the number and duration of examinations and rescue bronchoscopy.
Time frame: During initial tube placement after anaesthesia induction (approximately 10 minutes).
Time from removal of the stylet after the blue cuff passes the vocal cords to confirmation of satisfactory right-sided double-lumen tube position.
Time frame: At entry into the thorax and 20 minutes after initiation of one-lung ventilation.
Surgeon-rated quality of lung collapse at entry into the thorax and 20 minutes later: excellent (complete collapse and excellent exposure), good (minor residual air), or poor (incomplete collapse affecting surgery).
Contact information is provided by the study sponsor or research team.
Diansan Su
Other
Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery: A Multicentre Randomized Controlled Trial
Acronym: RIGHT-VDLT
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