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临床试验/NCT03709979
NCT03709979已完成不适用

Inönü University Department of Anesthesia

Inonu University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年1月21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
96
试验地点
1
主要终点
Percentage of glottic opening score

研究概览

简要总结

The aim of this study is to demonstrate the effect of C-Mac videolaryngoscopy with Miller Blade size 0 and 1 on the intubation conditions in children less than 2 years age with a roll inserted under the shoulders.

详细描述

The laryngoscopic view of the glottis is improved when the angle of the line of vision between the pharyngeal - laryngeal axis and the oral cavity axis is narrow. A roll inserted under the shoulders of the infant will help line up the oral, laryngeal, and pharyngeal axes making direct laryngoscopy easier.

The investigators hypothesized that laryngoscopic view and intubation conditions using C-Mac videolaryngoscope with Miller Blade size 0 and 1 would be better with a roll under shoulder in children under 2 years.

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
— 至 24 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •less than 2 years age undergoing general anaesthesia with tracheal intubation for elective surgery
  • •American Society of Anesthesiologists' physical status either 1 or 2 are included

排除标准

  • •upper respiratory tract infection within the previous 4 weeks
  • •airway difficulties in the preoperative evaluation
  • •unstable reactions during intubation

研究组 & 干预措施

C-MAC with folded towel position

Active Comparator

Children will be intubated by C-MAC videolaryngoscope with placing a folded towel under the shoulder.

干预措施: C-MAC videolaryngoscope (Device)

C-MAC with flat position

Placebo Comparator

Children will be intubated by C-MAC videolaryngoscope with flat position (non-inserted a folded towel)

干预措施: C-MAC videolaryngoscope (Device)

结局指标

主要结局

Percentage of glottic opening score

时间窗: immediately before endotracheal intubation

Percentage of glottic opening score of 100% denotes visualization of the entire glottis, from the anterior commissure of the vocal cords to the inter-arytenoid notch. If no part of the glottic opening was visualized, the POGO score was recorded as 0%

次要结局

  • Time to intubation(From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes)

研究者

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

Zekine Begec

Professor

Inonu University

研究点 (1)

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