Evaluation of Videolaryngoscopy (McGrath Mac) Compared to Direct Laryngoscopy for Rapid Sequence Intubation in Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- First pass Intubation success rate
研究概览
简要总结
Videolaryngoscope (Macintosh-type blade) compared with direct laryngoscopy for rapid sequence intubation in the operating room
详细描述
Video laryngoscopy (VL) is a etablished method of achieving tracheal intubation and there is evidence to show that visualisation of larynx can be improved using VL in failed tracheal Intubation (NAP 4 Report). VL has been shown to improve first attempt success compared to direct laryngoscopy in many clinical settings including intensive care unit (ICU) and emergency department (ED). This is a proposed comparison study of a VL, use in patients with a high risk for pulmonary Aspiration and requiring tracheal Intubation. An national, multi-center, prospective randomized comparative trial is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.
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
- •Age ≥ 18 Years
- •capacity to consent
- •Present written informed consent of the research participant
排除标准
- •Age <18 years
- •Existing pregnancy
- •Lack of consent
- •inability to consent
- •Difficult Airway / Defined Indications for awake intubation
- •Participation in another study
结局指标
主要结局
First pass Intubation success rate
时间窗: at intubation in 60 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
次要结局
- Cormack and Lehane Classification(< 120 seconds)
- adverse events(after 24 hours)
- Time to ventilation(at intubation in 120 seconds)
- Overall success rate(< 120 seconds)
- Intubation difficult score(< 120 seconds)
- complications(< 120 seconds)
研究者
Marc Kriege, MD
PD Dr. med. habil. Marc Kriege
Johannes Gutenberg University Mainz