A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.
详细描述
The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing general anesthesia using a supraglottic airway device
- •3 to 9 years of age
- •20 to 30 kilograms in weight
排除标准
- •History of a difficult airway
- •Active gastrointestinal reflux
- •Active upper respiratory tract infection
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 2 months
次要结局
未报告次要终点
研究者
Narasimhan Jagannathan
primary investigator
Ann & Robert H Lurie Children's Hospital of Chicago
