A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Time to Intubation
研究概览
简要总结
The purpose of this study is to determine whether the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.
详细描述
The goal of this prospective randomized study is to compare the Ambu KingVision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope.
The primary outcome of the study will be time to successful intubation. Other outcomes of clinical relevance such as first attempt success rates of intubation, grade of laryngeal view, percentage of glottic opening, number of insertion attempts, hemodynamic responses, 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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at Lurie Children's Hospital undergoing surgery/procedure where intubation is indicated
- •American Society of Anesthesiology Class I-III patients
排除标准
- •Children with an expected difficult airway
- •A bleeding or blood clotting disorder
研究组 & 干预措施
Direct Laryngoscopy
The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope.
干预措施: Miller Direct Laryngoscopy (Device)
KingVision Video Laryngoscope
The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade.
干预措施: Ambu KingVision Video Laryngoscope aBlade (Device)
结局指标
主要结局
Time to Intubation
时间窗: Assessed intraoperatively at time of intubation
Three timepoints will be recorded, beginning with insertion of the device past the lips into the mouth. These will include time to optimal glottic view, time to removal of device from mouth, and time to first CO2 capnography upstroke. The primary outcome measure will be total time to intubation, as the sum of all three timepoints.
次要结局
- First Attempt Success Rate of Tracheal Intubation(Assessed intraoperatively at time of intubation)
- Grades of Laryngeal View(Assessed intraoperatively at time of intubation)
- Intubation Adjustments & Ease of Use(Assessed intraoperatively following intubation)
- Hemodynamic Parameters - Heart Rate(Assessed intraoperatively at time of and following intubation)
- Hemodynamic Parameters - Blood Pressure(Assessed intraoperatively at time of and following intubation)
- Intraoperative Complications(Assessed intraoperatively)
- Postoperative Complications(Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery)
研究者
Narasimhan Jagannathan
Primary Investigator
Ann & Robert H Lurie Children's Hospital of Chicago