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| Name | Class |
|---|---|
| Charta Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| visual bronchial blocker group（VBB） | Experimental | Laryngeal Mask Airway(LMA) size selection based on patient weight (≥70kg: size 5, 50-70kg: size 4, <50kg: size 3)；Standard LMA insertion technique in supine position；Visual bronchial blocker inserted through LMA central channel；Blocker advancement under direct vision to identify carina |
|
| double-lumen endotracheal tube group（DLT） | Active Comparator | Size selection based on patient gender and height: Male: >180cm (37F), 160-180cm (35F), <160cm (32-35F)；Female: >160cm (35F), <155cm (32F), 155-160cm (individualized)；Standard laryngoscopy and DLT insertion；Fiberoptic bronchoscopy confirmation of positioning；Tracheal cuff pressure 25 cmH2O, bronchial cuff pressure 30 cmH2O |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| visual bronchial blocker (VBB) | Device | lung isolation with visual bronchial blocker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pharyngolaryngeal injuries within postoperative 24 hours | sore throat and hoarseness | within postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pharyngolaryngeal injuries within postoperative an hour | sore throat and hoarseness | within postoperative an hour |
| Incidence of pharyngolaryngeal injuries within postoperative 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingxiang Wu | Shanghai Chest Hospital | Study Director |
| Tingting Li | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | 200030 | China | |||
| Shanghai Pulmonary Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41469076 | Derived | Zhang Y, Li T, Wei J, Bao R, Lv X, Wang JF, Wu J. Laryngeal mask airway combined with visual bronchial blocker versus double-lumen tube for lung isolation in video-assisted thoracoscopic surgery: a protocol for a multicentre randomised controlled trial. BMJ Open. 2025 Dec 30;15(12):e110539. doi: 10.1136/bmjopen-2025-110539. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| double-lumen endotracheal tube (DLT) | Device | lung isolation with double-lumen endotracheal tube |
|
sore throat and hoarseness
| within postoperative 48 hours |
| Intraoperative device displacement | lung re-expansion, airway pressure changes | during the operation |
| Intraoperative hypoxemia | SpO2 < 91% | during the operation |
| Lung collapse quality | 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 ) | at 5, 10, and 20 minute during single-lung ventilation |
| Intubation time | from mouth opening to successful device placement | during anesthesia procedure |
| Hemodynamic changes | blood pressure variations before and after intubation | during anesthesia procedure |
| Recovery quality: post-extubation cough | 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) | periprocedural (during anesthesia recovery) |
| Device-related complications | intraoperative displacement, air leak, repositioning requirements | during the operation |
| Length of hospital stay | 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. | perioperative/periprocedural |
| Shanghai |
| 200433 |
| China |
| The Second Military Medical University Changhai Hospital | Shanghai | 200433 | China |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |