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

Официальное название

Video-guided Versus Conventional Right-sided Double-Lumen Tubes for One-Lung Ventilation in Thoracoscopic Surgery: A Multicentre Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство Conventional right-sided double-lumen tube
  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.

Первичные конечные точки

• Successful initial right-sided double-lumen tube placement [Срок оценки: From initial right-sided double-lumen tube insertion after anaesthesia induction until confirmation of satisfactory tube position before one-lung ventilation (approximately 10 minutes).]

Вторичные конечные точки (6)

• Right upper-lobe bronchial obstruction [Срок оценки: During initial tube positioning, before one-lung ventilation (approximately 10 minutes).]
• Intraoperative tube displacement and repositioning [Срок оценки: From initiation of one-lung ventilation until the end of surgery (approximately 1-3 hours).]
• Airway-related complications [Срок оценки: From tube insertion until 24 hours after surgery.]
• Fibreoptic bronchoscopy utilisation [Срок оценки: From initial tube placement until the end of surgery (approximately 1-3 hours).]
• Airway management time [Срок оценки: During initial tube placement after anaesthesia induction (approximately 10 minutes).]
• Lung collapse and surgical exposure quality [Срок оценки: At entry into the thorax and 20 minutes after initiation of one-lung ventilation.]

Критерии участия

Критерии включения

• Adults aged 18 years or older.
• American Society of Anesthesiologists physical status I-III.
• Scheduled for elective thoracoscopic surgery requiring lung isolation with a right-sided double-lumen tube for one-lung ventilation.
• Able to provide written informed consent.

Критерии исключения

• 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.
• Known or anticipated difficult airway.
• Requirement for rapid-sequence induction.
• Emergency surgery.
• Previous thoracic surgery within 4 weeks before enrolment.
• Active systemic infection or known/suspected pulmonary tuberculosis within 4 weeks before enrolment.
• Severe respiratory instability that, in the investigator's judgement, makes trial participation unsafe.
• Concurrent participation in another interventional clinical trial that could interfere with this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Китай · 3 центра

• The First Affiliated Hospital, Zhejiang University School of Medicine, — Ханчжоу
• Affiliated Hospital of Jiaxing University（The First Hospital of Jiaxing） — Jiaxing
• The Second Affiliated Hospital of Jiaxing University（The Second Hospital of Jiaxing） — Jiaxing

Идентификаторы

NCT: NCT07362797 · ZJU2025C144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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