Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Best view of the glottic structures
研究概览
简要总结
In the presented study, our aim was to compare intubation conditions regarding the modified Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
详细描述
Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.
An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.
Therefore, our aim was to compare intubation conditions regarding the modified Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients requiring general anesthesia for orthopedic surgery
排除标准
- •known or expected difficult airway
- •undergoing urgent or emergent surgery
- •non-fasted
- •American Society of Anesthesiology Class (ASA) IV-VI
- •no consent for participation
研究组 & 干预措施
Intervention
All patients received the same treatment.
- Laryngscopy with C-MAC PM + Macintosh blade
- Laryngscopy with C-MAC PM + D-Blade
- Intubation with C-MAC PM + D-Blade
干预措施: Macintosh blade (Device)
Intervention
All patients received the same treatment.
- Laryngscopy with C-MAC PM + Macintosh blade
- Laryngscopy with C-MAC PM + D-Blade
- Intubation with C-MAC PM + D-Blade
干预措施: D-Blade (Device)
Intervention
All patients received the same treatment.
- Laryngscopy with C-MAC PM + Macintosh blade
- Laryngscopy with C-MAC PM + D-Blade
- Intubation with C-MAC PM + D-Blade
干预措施: Intubation (Device)
结局指标
主要结局
Best view of the glottic structures
时间窗: 120 seconds after induction of narcosis
Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system
次要结局
- Evaluate the process of Intubation using a questionnaire(Directly after successful tracheal intubation)
- Subjective assessment of satisfaction using numeric rating scale(Directly after successful tracheal intubation)
研究者
Dr. med. Florian Raimann
Principal Investigator
Johann Wolfgang Goethe University Hospital