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临床试验/NCT03028896
NCT03028896已完成不适用

Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion

Seoul National University Bundang Hospital0 个研究点目标入组 132 人开始时间: 2015年4月2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
132
主要终点
First Attempt Success Rate

研究概览

简要总结

The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.

详细描述

One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists class I - II
  • •Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM

排除标准

  • •known difficult airway
  • •mouth opening less than 2.5 cm
  • •limited extension of neck
  • •recent sore throat
  • •gastroesophageal reflux disease

研究组 & 干预措施

standard

No Intervention

In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.

rotational

Experimental

After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.

干预措施: 90° rotational technique (Procedure)

结局指标

主要结局

First Attempt Success Rate

时间窗: at induction

the first attempt success rate of insertion of LMA FlexibleTM

次要结局

  • Insertion Time(at induction)
  • Oropharyngeal Leak Pressure(at induction)
  • Number of Participants With Blood Staining on the Laryngeal Mask Airway(post op 1min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

BON WOOK KOO

associator professor

Seoul National University Bundang Hospital

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