Comparison of the LMA Protector and the I-gel in Anesthetized Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Oropharyngeal airway leak pressure
研究概览
简要总结
Investigators aim to compare two supraglottic airway devices; the i-gel and the newly developed laryngeal mask airway protector in terms of airway sealing effect, the insertion success rate, and the incidence of complications in anesthetized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requirement for mechanical ventilation under general anesthesia
排除标准
- •Surgical position other than supine position
- •Tumors or anatomical abnormalities in the upper airway
- •Known or predicted difficult airway
- •Body mass index > 30 kg/m2
- •Required postoperative mechanical ventilation
- •Head and neck surgery
- •Aspiration tendency
研究组 & 干预措施
I-gel group
After the induction of anesthesia, I-gel is inserted into the oropharyngeal space.
干预措施: I-gel (Device)
LMA protector group
After the induction of anesthesia, laryngeal mask airway protector is inserted into the oropharyngeal space.
干预措施: Laryngeal mask airway protector (Device)
结局指标
主要结局
Oropharyngeal airway leak pressure
时间窗: At 5 min after the insertion of i-gel or LMA protector
Oropharyngeal airway leak pressure is measured by closing the expiratory valve of the circle system at a fresh gas flow of 3 L/min and observing the airway pressure at equilibrium.
次要结局
- Ease of insertion(During the insertion of i-gel or LMA protector)
- The incidence and severity of postoperative sore throat(At 1 and 24 h after surgery)
- The accuracy of insertion location of the device in the oropharyngeal space(At 15 min after the insertion of i-gel or LMA protector)
- Insertion time(During the insertion of i-gel or LMA protector)
- Blood staining on the i-gel or LMA protector(Immediately after removal of i-gel or LMA protector)
- Number of insertion attempt for the successful placement(During the insertion of i-gel or LMA protector)
- Ease of gastric tube insertion(At 25 min after the insertion of i-gel or LMA protector)
研究者
Jin-Young Hwang
Associate professor
SMG-SNU Boramae Medical Center