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临床试验/NCT00626951
NCT00626951已完成不适用

The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients

Medical University Innsbruck2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
2
主要终点
Oropharyngeal leak pressure

研究概览

简要总结

The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients

详细描述

The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiology physical status grade I-II
  • Age 18-80 yr
  • Elective gynecological surgery
  • Supine position

排除标准

  • Known or predicted difficult airway
  • Body mass index >35 kg m-2
  • Risk of aspiration

结局指标

主要结局

Oropharyngeal leak pressure

时间窗: 5 min

次要结局

  • Ease of insertion(1 min)

研究者

发起方
Medical University Innsbruck
申办方类型
Other

研究点 (2)

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