Pulmonary Neoplasm
Conditions
Keywords
pulmonary resection, one-lung ventilation, pharyngolaryngeal injuries, lung isolation devices
Brief 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.
Interventions
DEVICEvisual bronchial blocker (VBB)
lung isolation with visual bronchial blocker
lung isolation with double-lumen endotracheal tube
Sponsors
Charta Foundation
Tingting Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Scheduled for elective VATS pulmonary resection under general anesthesia * American Society of Anesthesiologists (ASA) physical status I-III * Body mass index (BMI) 18.5-30.0 kg/m² * Written informed consent
Exclusion criteria
* Anticipated difficult airway (Mallampati class IV, previous difficult intubation, airway abnormalities) * Gastroesophageal reflux disease or gastric retention * Active pulmonary infection or bleeding * Severe pulmonary dysfunction (FEV1 \<50% predicted) * Previous lung surgery or bilateral lung surgery * Cognitive impairment affecting outcome assessment * Chronic throat pain or voice abnormalities within 24 hours preoperatively * Abnormal right upper lobe bronchial anatomy on preoperative CT for right-sided procedures * Any condition deemed unsuitable for study participation by anesthesiologist or surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pharyngolaryngeal injuries within postoperative 24 hours | within postoperative 24 hours | sore throat and hoarseness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pharyngolaryngeal injuries within postoperative 48 hours | within postoperative 48 hours | sore throat and hoarseness |
| Intraoperative device displacement | during the operation | lung re-expansion, airway pressure changes |
| Intraoperative hypoxemia | during the operation | SpO2 \< 91% |
| Lung collapse quality | 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 ) |
| Incidence of pharyngolaryngeal injuries within postoperative an hour | within postoperative an hour | sore throat and hoarseness |
| Hemodynamic changes | during anesthesia procedure | blood pressure variations before and after intubation |
| Recovery quality: post-extubation cough | 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) |
| Device-related complications | during the operation | intraoperative displacement, air leak, repositioning requirements |
| Length of hospital stay | 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. |
| Intubation time | during anesthesia procedure | from mouth opening to successful device placement |
Countries
China
Outcome results
None listed