Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Leakage pressure [cmH2O]
研究概览
简要总结
The purpose of this study is determine safety and efficiency of mechanical ventilation in children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA Supreme). The main interest is leakage pressure of oropharynx and stomach. The null hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The alternative hypothesis is that there is a difference in leakage pressure.
详细描述
Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters will be measured.
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
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 1-10 years
- •ASA I - III
- •Elective procedure in general anaesthesia
- •Parental informed consent
排除标准
- •Non fasting patient
- •Body mass index > 35 kg/m2
- •Cervical spine pathologies or peripheral neurologic deficiences
- •Malformations of upper airway or head
- •Anamnestic hiatus hernia or esophageal reflux
- •Status post operation of stomach or esophagus
- •Recurrent respiratory infection or obstructive airway disease
- •Non elective procedure
结局指标
主要结局
Leakage pressure [cmH2O]
时间窗: 1min
After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation
次要结局
- Efficient ventilation [mL],(3min)
- tidal volume [mL],(3 minutes)
- stomach insufflation [yes or no](3 minutes)
研究者
Peter Paal
Peter Paal, MD, DESA, EDIC
Medical University Innsbruck