A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
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
- 否
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
研究组 & 干预措施
Ambu King Vision Video Laryngoscope aBlade System
The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement.
干预措施: Ambu King Vision Video Laryngoscope aBlade (Device)
Direct Laryngoscope
The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement.
干预措施: Direct Laryngoscopy via Miller Straight Blade (Device)
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
- Ease of Endotracheal Tube Passage(Assessed intraoperatively at time of intubation)
- 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.)
研究者
Narasimhan Jagannathan
Primary Investigator; M.D.
Ann & Robert H Lurie Children's Hospital of Chicago