Impact of Laryngeal Mask Combined With Visual Bronchial Blocker on Pharyngolaryngeal Injuries After Pulmonary Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Incidence of pharyngolaryngeal injuries within postoperative 24 hours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
visual bronchial blocker group（VBB）
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
干预措施: visual bronchial blocker (VBB) (Device)
double-lumen endotracheal tube group（DLT）
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
干预措施: double-lumen endotracheal tube (DLT) (Device)
结局指标
主要结局
Incidence of pharyngolaryngeal injuries within postoperative 24 hours
时间窗: within postoperative 24 hours
sore throat and hoarseness
次要结局
- Intraoperative device displacement(during the operation)
- Length of hospital stay(perioperative/periprocedural)
- Incidence of pharyngolaryngeal injuries within postoperative an hour(within postoperative an hour)
- Incidence of pharyngolaryngeal injuries within postoperative 48 hours(within postoperative 48 hours)
- Lung collapse quality(at 5, 10, and 20 minute during single-lung ventilation)
- Intubation time(during anesthesia procedure)
- Recovery quality: post-extubation cough(periprocedural (during anesthesia recovery))
- Intraoperative hypoxemia(during the operation)
- Device-related complications(during the operation)
- Hemodynamic changes(during anesthesia procedure)
研究者
Tingting Li
Attending physician
Shanghai Chest Hospital