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临床试验/NCT02048657
NCT02048657已完成不适用

The Efficiency of ProSeal Laryngeal Mask Airway Insertion: Compared the Techniques of Foley Airway Stylet Tool With Introducer-Tool

Kaohsiung Medical University Chung-Ho Memorial Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2008年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Number of participants with successful airway establishment

研究概览

简要总结

Due to its soft cuff easily folded to impede ProSeal LMA insertion, many tools are developed. The aim of the study is to investigate the efficiency of ProSeal LMA insertion guided by a soft, direct optical Foley airway stylet tool (FAST) and compared with the standard introducer-tool (I-Tool).

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with American Society of Anesthesiologists physical status I-II
  • aged 20-65 years
  • requiring LMA Intubation under general anesthesia
  • unlimited mouth open
  • unlimited neck motion

排除标准

  • mouth open < 3 cm
  • limited neck motion
  • BMI≧35 kg/m2

研究组 & 干预措施

Foley group

Experimental

The Foley Airway Stylet Tool was used to guide ProSeal LMA insertion

干预措施: Foley Airway Stylet Tool (Device)

I-Tool group

Experimental

the ProSeal LMA was inserted with a standard introducer-tool

干预措施: introducer-tool (Device)

结局指标

主要结局

Number of participants with successful airway establishment

时间窗: half an hour

successful airway establishment is defined as adequate ventilation with ProSeal LMA and its alignment with viewing of proper glottic and esophageal positions.

次要结局

  • postoperative sore throat(2 days)
  • hoarseness(2 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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