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临床试验/NCT04229862
NCT04229862已完成不适用

Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年2月14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
110
试验地点
1
主要终点
First attempt success rate

研究概览

简要总结

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.

详细描述

The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who are scheduled transurethral bladder tumor resection under general anesthesia
  • •20-79 years of age
  • •American Society of Anesthesiologists physical status ≤3
  • •Patients who are voluntarily agreed to this clinical study

排除标准

  • •History of difficult airway
  • •Expected difficult airway by physical examination
  • •Unstable teeth or teeth loss
  • •Obesity (body mass index ≥ 30)
  • •Recent history of upper respiratory infection
  • •Patients who are not fasted or who are at risk of aspiration

研究组 & 干预措施

Evaluation with 14 cm high pillow

Experimental

When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow.

干预措施: Laryngeal mask airway insertion (Procedure)

Evaluation with 7 cm high pillow

Active Comparator

When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow.

干预措施: Laryngeal mask airway insertion (Procedure)

结局指标

主要结局

First attempt success rate

时间窗: Immediately after mask airway insertion

The rate of success at the first attempt of laryngeal mask airway insertion

次要结局

  • The percentage of glottic opening score(Immediately after mask airway insertion)
  • Laryngeal mask airway insertion-related patient satisfaction(At postoperative 6 hours)
  • Oropharyngeal leak pressure(Immediately after mask airway insertion)
  • Reposition rate(After mask airway insertion (up to end of surgery))
  • Second attempt success rate(Immediately after mask airway insertion)
  • Third attempt success rate(Immediately after mask airway insertion)
  • Complications associated with laryngeal mask airway insertion(Up to postoperative 3 days)

研究者

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

Young-Kug Kim

Principal Investigator

Asan Medical Center

研究点 (1)

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