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临床试验/NCT02952690
NCT02952690已完成不适用

Clinical Comparison of Different Stylet Angles for Orotracheal Intubation Using Glidescope® Video Laryngoscope in Children

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年12月最近更新:
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
120
试验地点
2
主要终点
Time to tracheal intubation

研究概览

简要总结

The purpose of this study is to evaluate the feasibility of endotracheal intubation via glidescope videolaryngoscope (GVL) using different curve of stylet in 120 children aged between 1 and 5 year old.

详细描述

Pediatric patients aged 1-5 year old are randomly assigned to one of two groups; standard curve (S) and tip-manipulated curve (T) groups. After routine anesthetic induction, endotracheal intubation is performed with GVL. Size of GVL blade is selected according to weight; GVL 0: <1.5kg, GVL 1:1.5-3.6kg, GVL 2: 1.8-10kg, GVL 2.5: 10-28kg). Before intubation, stylet curve is differently manipulated according to group. The style is curved in accordance with the curve of GVL blade in S group, whereas the distal tip of style is additionally bended to the left (15-20 degree) in T group.

Time from visualization of glottis with GVL to approaching of endotracheal tube to glottis, and time to completion of intubation are measured. In addition, the easiness of intubation is assessed using Visual Analogue Scale (0: extremely easy, 10: extremely difficult) and will be compared in both groups.

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
Single (Participant)

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged between 1 and 5 years who are scheduled for elective surgery
  • American Society of Anesthesiologist physical status I, II

排除标准

  • History of asthma
  • Active upper respiratory infection
  • Significant cardiopulmonary disease

研究组 & 干预措施

standard curve group

Active Comparator

The style is curved in accordance with the curve of GVL blade in this group.

干预措施: Glidescope® with standard-curved tip (Device)

tip-manipulated curve group

Experimental

The style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree) in this group.

干预措施: Glidescope® with tip manipulated stylet (Device)

结局指标

主要结局

Time to tracheal intubation

时间窗: up to 3 min after insertion of GVL

From the insertion of GVL to completion of endotracheal intubation

次要结局

  • Time to approaching of endotracheal tube tip to glottis(up to 3 min after insertion of GVL)
  • Successful endotracheal intubation in 30 seconds(up to 3 min after insertion of GVL)
  • Number of attempt for glottis passage of endotracheal tube(up to 3 min after insertion of GVL)
  • The change in stylet angle(up to 3 min after insertion of GVL)
  • Visual analogue scale for the easiness of endotracheal intubation(up to 3 min after insertion of GVL)

研究者

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

Hee-Soo Kim

Professor

Seoul National University Hospital

研究点 (2)

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