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临床试验/NCT02384564
NCT02384564Unknown不适用

A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

Ann & Robert H Lurie Children's Hospital of Chicago0 个研究点目标入组 140 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
140
主要终点
First Attempt Success Rate of Tracheal Intubation

研究概览

简要总结

The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.

详细描述

The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
1 Day 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA (American Society of Anesthesiologists) I-III classified patients
  • Patients undergoing procedure where an endotracheal tube would be normally utilized

排除标准

  • Children with expected difficult airways
  • Coagulopathy

结局指标

主要结局

First Attempt Success Rate of Tracheal Intubation

时间窗: Assessed intraoperatively at time of intubation

An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.

次要结局

  • Grades of Laryngeal View(Assessed intraoperatively at time of intubation)
  • Time to Successful Intubation(Assessed intraoperatively at time of intubation)
  • Intraoperative Complications(Assessed intraoperatively for the duration of the surgery)
  • Postoperative Complications(Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.)
  • Ease of Endotracheal Tube Passage(Assessed intraoperatively at time of intubation)

研究者

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

Narasimhan Jagannathan

Primary Investigator; M.D.

Ann & Robert H Lurie Children's Hospital of Chicago

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