Endotracheal Intubation Using Videolaryngoscopy Versus Conventional Direct Laryngoscopy: A Randomized Multiple Cross-over Cluster Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,736
- 试验地点
- 1
- 主要终点
- The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
研究概览
简要总结
The investigators will evaluate the endotracheal intubation using video laryngoscopy versus conventional direct laryngoscopy on intubation success, quantified by the number of intubation attempts. The question is important because video laryngoscopes are more expensive than conventional direct laryngoscopes. The additional cost might be justified if video systems improve intubation success and reduce airway trauma. But if they do not, the extra cost would not be justified
详细描述
The investigators propose to enroll participants scheduled for elective or emergent cardiac, thoracic, or vascular surgery in the designated operating room suite who require endotracheal intubation for general anesthesia.
A cluster randomized multiple crossover design is used for this trial. The cardiac surgical suites will be divided into 2 sets of 11 operating rooms. Each set is treated as a unit and randomized to receive video or direct laryngoscopy in 1-week blocks, always with 1 set randomized to each approach. For analysis, each operating room within a set will be considered a separate cluster. Randomization will be conducted weekly on a 1:1 unstratified basis, using computer-generated codes maintained in a web-based system. Investigators access these codes a day before each new treatment block begins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective or emergent surgery requiring oral endotracheal intubation for general anesthesia.
排除标准
- •The attending anesthesiologist prefers a specific approach for a particular patient
- •Awake fiberoptic intubation is clinically indicated
- •Insertion of double-lumen tube.
研究组 & 干预措施
videolaryngoscopy
Initial intubation performed using GlideScope videolaryngoscope.
干预措施: GlideScope videolaryngoscope (Verathon, Bothell, Washington 98011) (Device)
conventional direct laryngoscopy
Initial intubation performed using direct laryngoscopy.
干预措施: Direct laryngoscopy (Device)
结局指标
主要结局
The Number of Intubation Attempts With the Initial Laryngoscopy Instrument.
时间窗: From the start time of intubation to time of the end of surgery up to 24 hours.
Intubation attempts is defined as introduction and subsequent removal of a laryngoscope blade into the oral cavity whether or not the trachea was intubated.
次要结局
- Intubation Failure(From the start time of intubation to time of the end of surgery.)
- Any Dental or Airway Injury(From the start time of intubation to time of the end of surgery.)