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临床试验/NCT00966186
NCT00966186已完成不适用

The 90-degree Rotational Insertion Technique for the Large Size ProSeal Laryngeal Mask Airway

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年11月1日最近更新:
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
120
试验地点
1
主要终点
Success of Insertion at First Attempt

研究概览

简要总结

The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

详细描述

ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
27 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists physical status I-II

排除标准

  • •Predicted difficult airway
  • •Mouth opening less than 2.5 cm
  • •Present sore throat
  • •High risk of aspiration

研究组 & 干预措施

Standard technique

Active Comparator

Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual (insertion with help of index finger insertion)

干预措施: Insertion fo ProSeal laryngeal mask airway (Procedure)

Rotational technique

Experimental

The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was fel

干预措施: Insertion fo ProSeal laryngeal mask airway (Procedure)

结局指标

主要结局

Success of Insertion at First Attempt

时间窗: 5 minute

次要结局

  • Insertion Time, Sealing Pressure and Complication(5 min - 4 hours)

研究者

申办方类型
Other

研究点 (1)

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