visual bronchial blocker (VBB)
Devicelung isolation with visual bronchial blocker
NCT Number: NCT07117539
The goal of this clinical trial is to assess the impact of laryngeal mask combined with visual bronchial blocker on pharyngolaryngeal injury after pulmonary resection in patients with pulmonary nodules. The main question it aims to answer is:
the incidence of postoperative pharyngolaryngeal injury within 24h : sore throat and hoarseness ? Researchers will compare the visual bronchial blocker group (VBB) with the double-lumen endotracheal tube group (DLT) to see if the visual bronchial blocker group can minimize laryngopharyngeal injury after pulmonary resection.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Shanghai Chest Hospital, Shanghai, China
Background: Video-assisted thoracoscopic surgery (VATS) necessitates effective lung isolation techniques. While double-lumen endotracheal tubes (DLT) remain the gold standard, they are associated with significant airway trauma and postoperative laryngopharyngeal morbidity. Laryngeal mask airway (LMA) combined with bronchial blockers represents a promising alternative; however, conventional bronchial blockers pose limitations including challenging positioning and potential airway injury. Novel visual bronchial blocker technology offers enhanced positioning accuracy and reduced airway manipulation, potentially minimizing laryngopharyngeal injury while maintaining effective lung isolation.
Objective: To compare the efficacy and safety of LMA combined with a visual bronchial blocker versus DLT for lung isolation in VATS, with a primary focus on reducing postoperative laryngopharyngeal injury.
Methods: This prospective, randomized, controlled, single-blind, multicenter clinical trial will enroll 270 patients scheduled for elective VATS anatomical lung resection. Participants will be randomly allocated (1:1 ratio) to either the visual bronchial blocker group (VBB group, n=135) or the DLT group (n=135) across three major thoracic surgery centers. The primary outcome is the incidence of laryngopharyngeal injury (sore throat and/or hoarseness) at 24 hours postoperatively. Secondary outcomes include laryngopharyngeal injury at 1 hour and 48 hours postoperatively, intraoperative device dislodgement, hypoxemia (SpO₂ < 90%), quality of lung collapse, airway instrumentation time, hemodynamic fluctuations, emergence quality, device-related complications, and hospital length of stay. Statistical analysis will be performed using SPSS 24.0, employing appropriate parametric and non-parametric tests.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lung isolation with visual bronchial blocker
lung isolation with double-lumen endotracheal tube
Time frame: within postoperative 24 hours
sore throat and hoarseness
Time frame: within postoperative an hour
sore throat and hoarseness
Time frame: within postoperative 48 hours
sore throat and hoarseness
Time frame: during the operation
lung re-expansion, airway pressure changes
Time frame: during the operation
SpO2 < 91%
Time frame: at 5, 10, and 20 minute during single-lung ventilation
The Lung Collapse Scale (LCS) is a standardized tool used in thoracic surgery to evaluate the degree of lung deflation during procedures requiring single-lung ventilation.(A score of 0: No lung collapse ; A score of 8: Satisfactory lung collapse.; A score of 10: Complete lung collapse )
Time frame: during anesthesia procedure
from mouth opening to successful device placement
Time frame: during anesthesia procedure
blood pressure variations before and after intubation
Time frame: periprocedural (during anesthesia recovery)
Post-extubation Cough Severity Scale (4-point Grading System) : Grade 0 (No cough); Grade 1( Mild cough: 1-2 episodes, duration <5 seconds ); Grade 2 (Moderate cough: 3-4 episodes, duration 5-15 seconds); Grade 3 (Severe cough ≥5 episodes, duration >15 seconds, with breath-holding and facial flushing)
Time frame: during the operation
intraoperative displacement, air leak, repositioning requirements
Time frame: perioperative/periprocedural
Surgery-to-Discharge Interval(SDI): measures the time from surgery end (e.g., leaving the operating room) to discharge.Assesses recovery efficiency and effectiveness of Enhanced Recovery After Surgery (ERAS) protocols.
Tingting Li
Other
Impact of Laryngeal Mask Combined With Visual Bronchial Blocker on Pharyngolaryngeal Injuries After Pulmonary Resection
Acronym: PLIAP
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