A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Measure of Intubation Success
研究概览
简要总结
This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.
详细描述
Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:
- •mallampati classification 3
- •mallampati classification 4
- •Reduced mouth opening (<3cm)
- •reduced cervical motion
- •history of previous difficult intubation or multiple laryngoscopy attempts
排除标准
- •Patients less than 18 years old, patients who are not fasted (>6 hrs. NPO)
- •Patients who have contraindications to the administration of neuromuscular blocking drugs
- •Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
- •Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.
研究组 & 干预措施
CMAC Video laryngoscope
Subjects will have their intubation attempted first with the CMAC video laryngoscope
干预措施: CMAC video laryngoscope (Device)
Macintosh blade
Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade
干预措施: Macintosh laryngoscope (Device)
结局指标
主要结局
Measure of Intubation Success
时间窗: During each intubation in a 14 month period
Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure
次要结局
- Intubation Time(During laryngoscopy procedure)
- Number of Participants Intubated With a Rescue Device(1 year)
- Number of Participants With Complications(1 year)
- Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.(1 year)
- Number of Particpants Requiring Adjuncts to Assist Intubation(1 year)
研究者
Michael Aziz
Associate Professor Department of Anesthesiology & Perioperative Medicine
Oregon Health and Science University