NCT06502028已完成不适用
Video Laryngeal Mask Versus Endotracheal Tube in Patients Undergoing Laparoscopic Cholecystectomy Surgery Under General Anesthesia: a Prospective Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Time required for VLMA insertion or intubation
研究概览
简要总结
The aim of this study is to investigate the effectiveness of using a video laryngeal mask for airway management in patients undergoing laparoscopic cholecystectomy.
详细描述
The investigators will compare the time required to secure the airway when inserting a video laryngeal mask (LMA) versus performing endotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 19 years old
- •Patients planned for elective laparoscopic cholecystectomy
排除标准
- •High risk of aspiration (e.g. gastro-esophageal reflux disease, hiatus hernia, pregnancy, history of gastrectomy)
- •Difficult airway (e.g. limitation of mouth opening, limitation of neck extension, oropharyngeal pathology)
- •Obesity (BMI > 30 kg/m2)
- •Tooth mobility
研究组 & 干预措施
Video LMA
Experimental
The airway is secured with a video laryngeal mask airway (VLMA).
干预措施: Video laryngeal mask airway (Device)
Control
Active Comparator
The participant is intubated with an endotracheal tube via direct laryngoscopy.
干预措施: Endotracheal tube (Device)
结局指标
主要结局
Time required for VLMA insertion or intubation
时间窗: After induction of anesthesia, before the operation starts.
Time required for VLMA insertion or intubation
次要结局
- Number of trials(After induction of anesthesia, before the operation starts.)
- Peak airway pressure(After video laryngeal mask airway insertion or intubation, before extubation)
- Minute ventilation(After video laryngeal mask airway insertion or intubation, before extubation)
- End tidal carbon dioxide(After video laryngeal mask airway insertion or intubation, before extubation)
- Oropharyngeal leak pressure(After video laryngeal mask airway insertion or intubation, before extubation)
- Traces of blood on airway device after extubation(After extubation, before transfer to PACU)
- Postoperative sore throat(24 hours after end of operation)
- Postoperative hoarseness(24 hours after end of operation)
研究者
研究点 (2)
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