Video Double-Lumen Tube for Secondary Pulmonary Resection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
During thoracic surgery, double-lumen endotracheal intubation with one-lung ventilation is routinely performed to optimize surgical exposure, facilitate operative manipulation, and prevent iatrogenic lung injury. In patients undergoing repeat pulmonary surgery, prior lung resection may lead to pleural adhesions and tracheobronchial distortion, which substantially increase the difficulty of bronchial intubation. Even with experienced operators, the malposition rate of conventional double-lumen tubes remains high. The video double-lumen tube enables continuous visualization of the trachea and carina during insertion, positioning, and one-lung ventilation, allowing real-time airway monitoring. However, no clinical studies have specifically investigated airway management in patients undergoing redo pulmonary surgery. This study aimed to evaluate the efficacy and safety of the video double-lumen tube during anesthesia in patients undergoing secondary pulmonary resection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
History of previous pulmonary resection.
Scheduled for elective pulmonary surgery.
Planned to receive a left-sided double-lumen tube.
Disqualifiers
Preoperatively predicted difficult airway (Mallampati ≥ III, Cormack-Lehane ≥ III).
Acute respiratory distress syndrome (ARDS) or respiratory failure within the past 3 months.
Uncontrolled asthma.
Confirmed pregnancy or current breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Video Double-Lumen Tube Group
DeviceUse the video double-lumen tube to perform left bronchial intubation under real-time visualization and continuously monitor its position.
Conventional Double-Lumen Tube Group
DeviceInsert a conventional left-sided double-lumen tube using standard intubation techniques.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Video Double-Lumen Tube GroupExperimental treatment 1 intervention
Group B: Conventional Double-Lumen TubeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Success rate of first-attempt bronchial intubation
Time frame
During the first intubation attemptSecondary outcomes
1
Intubation time
Time frame
Measured from insertion of the video laryngoscope into the mouth until confirmation of correct tube position2
Requirement for and number of fiberoptic bronchoscopy uses
Time frame
During the entire intraoperative period3
Frequency of intraoperative tube repositioning
Time frame
During the entire intraoperative period4
Surgeon's rating of lung collapse quality
Time frame
During the entire intraoperative periodOther outcomes
1
Incidence of intraoperative hypoxemia
Time frame
During the entire intraoperative periodSponsors and contacts
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Source ClinicalTrials.gov
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