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临床试验/NCT00500916
NCT00500916已完成不适用

Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway

Medical University Innsbruck2 个研究点 分布在 1 个国家开始时间: 2007年3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
试验地点
2
主要终点
Insertion success rate

研究概览

简要总结

The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.

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
None

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patient
  • Body mass index <35 kg/m2
  • Difficult airway

排除标准

  • Body mass index >35 kg/m2
  • Risk of aspiration

结局指标

主要结局

Insertion success rate

时间窗: 5 min

次要结局

  • Time to successful insertion(5 min)

研究者

发起方
Medical University Innsbruck
申办方类型
Other

研究点 (2)

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