The C-MAC Videolaryngoscope Compared With Conventional Laryngoscopy for Rapid Sequence Intubation at the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Success Rate
研究概览
简要总结
All patients undergoing emergent endotracheal intubation (RSI) at the Emergency Department will be screened for inclusion in this clinical study. The indication of endotracheal intubation is an exclusively clinical decision and is not affected by this study protocol in any aspect.
If fulfilling the In- and exclusion criteria's, patient will be randomly assigned to one of two groups
- C-MAC Videolaryngoscope in appropriate size
- conventional endotracheal intubation using Macintosh Blade in appropriate size
Randomization (1:1) will be based on computer-generated codes maintained in sequentially numbered opaque envelopes that will be opened immediately before randomization.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring emergency Rapid Sequence Intubation at the emergency department
- •Male and Female subjects 18 years to 99 years of age
- •Written confirmation by a physician not involved in this study
- •Written informed consent by the participant (obtained afterwards)
- •Patient not showing remarkable rejection in participation in this study
排除标准
- •Maxilla-Facial trauma
- •Immobilized cervical spine
- •Indication for fiberoptic guided intubation (known difficult airway)
- •Ongoing Cardio-Pulmonary-Resuscitation (CPR)
- •Involvement in any other clinical trial during the course of this trial, within a period of 30 days prior to its beginning or 30 days after its completion
- •Severe or immediately life-treating injury requiring immediate medical treatment
研究组 & 干预措施
conventional endotracheal intubation
Patients assigned to this group will be intubated using conventional Macintosh blade in adequate size.
干预措施: Macintosh blade (Device)
C-MAC
Patients assigned to this group will be intubated using C-MAC videolaryngoscope in adequate size.
干预措施: C-MAC videolaryngoscope (Device)
结局指标
主要结局
Success Rate
时间窗: 10 minutes
defined as successful placement of endotracheal tube within the trachea and
次要结局
- time to intubation(10 minutes)
- Laryngoscopic view(10 minutes)
- Number of intubation attempts(10 minutes)
- Unrecognized esophageal intubation(10 minutes)
- Ease of intubation (1-5)(10 minutes)
- Violations of the teeth(10 minutes)
- Necessity of using further, alternative airway devices for successful intubation (if randomized airway device failed)(10 minutes)
- Maximum drop of saturation(10 minutes)