The Comparison of Two Different Methods of Partial Inflation of Cuff for Facile Insertion of Laryngeal Mask Airway in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- The intra-cuff pressure
研究概览
简要总结
Partial cuff inflation before insertion is generally used for laryngeal mask airway insertion in children. However, it is not proven how much the cuff should be inflated. The aim of this study is to compare efficacy between the method using the resting volume and the method using half the maximum volume for partial cuff inflation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children (0-9 years of age)
- •children who is scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using LMA-classic
排除标准
- •patients with an abnormal airway
- •patients with reactive airway disease
- •patients with gastroesophageal reflux disease
- •patients with chronic respiratory disease
- •patients who has a history of an upper respiratory tract infection in the preceding 6-week period
研究组 & 干预措施
resting volume group
干预措施: The cuff inflation by the resting volume (Device)
maximum volume group
干预措施: The cuff inflation by the maximum volume (Device)
结局指标
主要结局
The intra-cuff pressure
时间窗: approximately 5 to 10 minutes after insertion of LMA.
1\) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
The leak volume
时间窗: approximately 5 to 10 minutes after insertion of LMA.
1\) After insertion of LMA, we confirm adequate ventilation. And then we measure intra-cuff pressure using cuff pressure manometer. 2) After confirming adequate ventilation, tidal volumes are measured using spirometer sensor attached anesthesia machine. Five corresponding inspiratory and expiratory tidal volumes are recorded and the difference between these is calculated as the leak volume. The time that measures the intra-cuff pressure and leak volume is approximately 5 to 10 minutes after insertion of LMA.
次要结局
未报告次要终点
研究者
Jeong-Rim LEE
Assistant Professor
Yonsei University