跳至主要内容
临床试验/NCT01385761
NCT01385761已完成不适用

A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

Ann & Robert H Lurie Children's Hospital of Chicago1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Narasimhan Jagannathan

primary investigator

Ann & Robert H Lurie Children's Hospital of Chicago

研究点 (1)

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