CTRI/2022/12/048423尚未招募不适用
To determine the clinical performance of Laryngeal Mask Airway Pro-seal when compared with Laryngeal Mask Airway Protector using video laryngoscope guided insertion technique in patient under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To compare oropharyngeal leak pressure (OLP) of LMA Pro-seal and LMA
研究概览
简要总结
| To determine the clinical performance of Laryngeal Mask Airway Pro-seal when compared with Laryngeal Mask Airway Protector using video laryngoscope guided insertion technique in patient under General Anesthesia. The primary outcome is to compare the oropharyngeal leak pressure and secondary outcomes are to compare the hemodynamic responses and complications |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to American Society of Anesthesiologists grade I or II
- •Age: above 18yrs and below 65yrs
- •Mouth opening > 5cm
- •Patients posted for short surgical procedures < 3hours.
排除标准
- •1.Emergency surgeries 2.Presence of an upper airway anatomic variation or pathology
- •Surgery requiring lateral or prone position
- •Body mass index greater than 30 kg/m2
- •Patients having aspiration tendency(full stomach, history of stomach surgery, gastroesophageal reflux, hiatal hernia, sore throat, upper respiratory airway infections).
结局指标
主要结局
To compare oropharyngeal leak pressure (OLP) of LMA Pro-seal and LMA
时间窗: At 10min
protector when inserted under vision guidance using video laryngoscope.
时间窗: At 10min
次要结局
- 1. To assess the ease and accuracy of device insertion, ease of gastric tube placement.(2. To detect the hemodynamic responses induced by airway insertion [blood pressure,)
研究者
研究点 (1)
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