A Randomized Comparison Between the Pentax AWS Video Laryngoscope and the Macintosh Laryngoscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Time to Intubation
研究概览
简要总结
This study will compare the Macintosh laryngoscope with the Pentax. The Pentax AWS is a novel airway management device that is designed to facilitate laryngoscopy and endotracheal intubation.
详细描述
100 obese patients (BMI 30 to 50) requiring orotracheal intubation for elective surgery will be randomly allocated to intubation with either a conventional Macintosh laryngoscope or with the Pentax AWS. Our study hypothesis is that use of Pentax AWS will make tracheal intubation easier to perform in the obese surgical patient (BMI 30 to 50), as evidenced by the time to complete the intubation process as well as an "Ease of Use" visual analog score (VAS) measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •subject is at least 18 years old
- •BMI between 30 and 50
- •scheduled for elective surgery requiring orotracheal intubation
排除标准
- •a known difficult airway
- •loose teeth
- •subject pregnancy
- •rapid sequence induction required
- •subject is unable to give consent
- •anesthesiologist considered use of the Pentax AWS to be contraindicated
- •special endotracheal tube (ETT) is needed for the case.
结局指标
主要结局
Time to Intubation
时间窗: time between sufficient muscle relaxant and placement of intubation tube, up to 100 seconds
time between sufficient muscle relaxant and placement of intubation tube
次要结局
- The Number of Patients With Bleeding(From the start of intubation until 24 hours after surgery)
- Ease of Intubation(From the start of intubation until 24 hours after surgery)
- The Number of Patients With Different Number of Intubation Attempts(From the start of intubation until 24 hours after surgery)
- Successful Intubation on the First Attempt(From the start of intubation until 24 hours after surgery)