Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,466
- 试验地点
- 2
- 主要终点
- intubation success
研究概览
简要总结
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.
详细描述
As airway management continues to evolve the investigators do not have an accurate statement of the success of direct laryngoscopy in daily clinical practice. The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to direct laryngoscopy. An international, multi-center, prospective randomized comparative trial (RCT) 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 No concurrent participation in another study
- •capacity to consent
- •Present written informed consent of the research participant
- •Elective surgery under general anesthesia
排除标准
- •Age <18 years
- •Existing pregnancy
- •Lack of consent
- •inability to consent
- •emergency patients
- •Emergency situations in the context of a Difficult Airway Management
- •ASA classification> 3
- •situations where the possibility of accumulated gastric contents
- •Participation in another study
研究组 & 干预措施
McGrath MAC
tracheal intubation using the McGrath MAC
干预措施: the McGrath MAC (Device)
Macintosh Laryngoscope
tracheal intubation using the Macintosh Laryngoscope
干预措施: the Macintosh Laryngoscope (Device)
结局指标
主要结局
intubation success
时间窗: at intubation; < 120 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
次要结局
- Cormack and Lehane Classification(< 120 seconds)
- Percentage of glottic opening(< 120 seconds)
- Number of attempts(< 120 seconds)
- IDS (intubation difficult score)(< 120 seconds)
研究者
Marc Kriege, MD
MD
Johannes Gutenberg University Mainz