LMA ProSeal & I-Gel : a Prospective Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Insertion success rate
研究概览
简要总结
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee. 222 patients will be enrolled in each group. The objectives of the study will be to compare insertion success rate, leak pressure, ventilatory parameters and adverse event rate.
详细描述
Supraglottic airway devices are now widely used for surgery requiring general anesthesia. Airway devices are safe and their morbidity rate is very low. The i-gel (Intersurgical Ltd, Wokingham, Berkshire, UK) is a new single-use non-inflatable supraglottic airway device that has not been evaluated in a comparative study.
The aim of this study is to compare i-gel with the LMA ProSeal in a randomized study. Anesthesia protocol is standardized. The supraglottic devices are compared in term of insertion success rate, leak pressure, ventilatory parameters and adverse events. The aim is to demonstrate an enhancement in term of insertion success rate and a diminution of the adverse events. Statistical analysis will used percentage, confidence interval and chi 2 or Fischer's exact test for qualitative data. Quantitative data will be analyzed in mean, standard deviation. Comparison will be made with a student t test or a wilcoxon test. P < 0,05 is statistically significant.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight > 30 kg
- •Surgery allowing the use of laryngeal mask as airway management
- •Written informed consent
排除标准
- •Difficult intubation criteria (defined by French Anesthesia-Reanimation Society)
- •Pulmonary disease
- •Gastroesophageal reflux antecedent
- •Coeliosurgery
- •Inhalation risk
- •Hiatus hernia
研究组 & 干预措施
1
LMA ProSeal
干预措施: Laryngeal mask insertion (LMA ProSeal) (Device)
2
I-Gel
干预措施: Laryngeal mask insertion (I-Gel) (Device)
结局指标
主要结局
Insertion success rate
时间窗: At firste attempt of insertion
次要结局
- Airway sealing pressure(Once, when efficient ventilation is reached)
- Accessibility for stomach tube insertion(Juste after laryngeal mask insertion)
- Perioperative morbidity(Perioperative period)
- Fibre-optic grade(After insertion)