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临床试验/NCT01738854
NCT01738854已完成不适用

The Comparison of Airway Sealing With the Laryngeal Mask Airway (LMA) Supreme at Different Intracuff Pressure in Children

Yonsei University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年11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
36
试验地点
2
主要终点
The oropharyngeal leak pressure volume

研究概览

简要总结

The laryngeal mask airway (LMA) supreme is a relatively new single-use supraglottic airway with modification. The parameters about airway sealing such as oropharyngeal leak pressure (OLP) and leakage volume are important markers of efficacy and safety when using the supraglottic airway. The airway sealing is related to the intracuff pressure of laryngeal mask airway. The aim of this study is to compare the airway sealing of the LMA supreme at various intracuff pressure in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Care Provider)

入排标准

年龄范围
— 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients (less than 108months of age)
  • scheduled for elective surgery undergoing general anesthesia using LMA supreme 1.5-2.5

排除标准

  • Patients with an abnormal airway,
  • reactive airway disease,
  • gastroesophageal reflux disease,
  • chronic respiratory disease,
  • a history of an upper respiratory tract infection

结局指标

主要结局

The oropharyngeal leak pressure volume

时间窗: approximately 5 minutes after adjusting intracuff pressure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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