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临床试验/NCT04745936
NCT04745936已完成不适用

Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2021年3月3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
114
试验地点
1
主要终点
Tube handling time

研究概览

简要总结

The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.

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
— 至 1 Year(Child)
性别
All
接受健康志愿者
否

入选标准

  • •① Infants under 1 year old scheduled for elective surgery under general anesthesia
  • •② American Society of Anesthesiology physical status I, II

排除标准

  • •Any pulmonary disease

研究组 & 干预措施

C-curve group (group C)

Experimental

In group C, stylet curvature is made similar to the natural curvature of endotracheal tube.

干预措施: Style curve similar to natural curvature of endotracheal tube (Other)

Hockey stick curve group (group H)

Active Comparator

In group H, stylet curvature is made similar to hockey stick shape.

干预措施: Style curve similar to hockey stick shape (Other)

结局指标

主要结局

Tube handling time

时间窗: during procedure

From glottis visualization to completion of tracheal intubation

次要结局

  • Number of external laryngeal manipulation(during procedure)
  • The location of the initial tube tip(during procedure)
  • Easiness of tracheal intubation(during procedure)
  • Total intubation time(during procedure)
  • Additional manipulation of stylet angle(during procedure)
  • Time to reaching glottis(during procedure)
  • Successful tracheal intubation(during procedure, within 30 sec)

研究者

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

Ji-Hyun Lee

Associate professor

Seoul National University Hospital

研究点 (1)

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