A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to ventilation (seconds)
研究概览
简要总结
In Pediatric both manikin and human studies have suggested that the video laryngoscopy is equally suitable to facilitate intubation compared to the direct laryngoscopy.
详细描述
The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new born and infants. In this manikin studie we want to compare different types of video laryngoscopes in a simulated normal and difficult infant airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
residents, fellows and attending with different level of experience
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •anesthesiologists or neonatal/pediatric intensive care medicice specialists with experience in securing pediatric airway
排除标准
- •participants without experience in pediatric airway management
研究组 & 干预措施
normal airway
Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
干预措施: normal airway (Device)
normal airway
Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
干预措施: difficult airway (Device)
difficult airway
Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
干预措施: normal airway (Device)
difficult airway
Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
干预措施: difficult airway (Device)
结局指标
主要结局
Time to ventilation (seconds)
时间窗: Assessed intraoperatively at time of intubation (seconds)
Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator
次要结局
- Grades of Laryngeal View (Cormack&Lehane Class)(Assessed intraoperatively at time of intubation)
- First attempt success rate of tracheal intubation (in 40 seconds)(Assessed intraoperatively at time of intubation)
- Use of ELM(Assessed intraoperatively at time of intubation)
- Intubation Adjustments & Ease of Use(Assessed intraoperatively following intubation)
研究者
Marc Kriege, MD
Dr. med. Marc Kriege, Dr. med. Nina Pirlich
Johannes Gutenberg University Mainz