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临床试验/NCT05515107
NCT05515107已完成不适用

Inönü University Department of Anesthesia

Inonu University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Percentage of glottic opening score

研究概览

简要总结

In this study, the investigators aim to evaluate the glottic visualization and time to intubation during laryngoscopy performed with the C-MAC VL size 1 Miller blade lifting the epiglottis or placing the tip of the blade on the base of the tongue (vallecula) in children younger than 2 years of age.

详细描述

Direct laryngoscopy (DL) is the most widely used method to ensure airway safety. In pediatric patients under two years of age, Miller laryngoscope blade is recommended as it removes the long and drooping epiglottis from the eye during laryngoscopy and shows the laryngeal entrance better.

In the classical definition, the tip of the Miller blade is placed behind the epiglottis. However, if the intubator wishes, the Miller blade tip can be placed on the root of the tongue (vallecula) and used as a Macintosh blade.

In the literature search, no study has been found so far comparing C-MAC VL 1 numbered Miller blade with intubation by removing the epiglottis or placing the blade on the vallecula. In this study, the investigators aimed to evaluate the glottic image and intubation time during laryngoscopy performed by lifting the epiglottis with the C-MAC VL No. 1 Miller blade or placing the tip of the blade on the base of the tongue in children under 2 years 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
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Younger than 2 years of age
  • ASA I and II patients
  • Elective surgery under general anesthesia with tracheal intubation

排除标准

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

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 (2)

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