NCT07117539

Impact of Different Lung Isolation Devices on Pharyngolaryngeal Injuries After Pulmonary Resection

Impact of Laryngeal Mask Combined With Visual Bronchial Blocker on Pharyngolaryngeal Injuries After Pulmonary Resection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Tingting Li · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Neoplasm

Interventions

Type	Name	Description
DEVICE	visual bronchial blocker (VBB)	lung isolation with visual bronchial blocker
DEVICE	double-lumen endotracheal tube (DLT)	lung isolation with double-lumen endotracheal tube

Timeline

• Start date: 2025-08-18
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2025-08-12
• Last updated: 2026-01-15

Locations

3 sites across 1 country: China