RIFL (Rigid and Flexing Laryngoscope) vs. Fiberoptic Bronchoscope: A Comparison of the Ease of Use During Intubation on Difficult Airways
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Time Until Proper Endotracheal Tube Placement
研究概览
简要总结
We will conduct a randomized trial comparing the success rate and time to intubation using the RIFL vs. the fiberoptic bronchoscope, as the latter is commonly held to be the gold standard of difficult airway devices. Specifically, we wish to compare the of intubation between the two devices in patients with potentially difficult airways as defined by an oropharyngeal class 3-4, BMI greater than 35, or in patients with a history of difficult intubation using direct laryngoscopy.
详细描述
Patients who require general anesthesia with endotracheal intubation will be identified the night prior to their surgery based upon the examination documented in their preoperative history and physical. If their body mass index achieves a calculated score of 35 or greater or they have an oropharyngeal class 4 airway then they will qualify to participate.
After written informed consent is obtained, The intubation method would be randomized as one of two groups: intubation via use of the fiberoptic bronchoscope or the RIFL. The intubation attempt will be terminated if the SpO2 <90, HR<50, there is traumatic injury, or time > 100sec. If terminated, the patient will be mask ventilated and the attending anesthesiologist would determine the subsequent technique that will be used for airway management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patients with known or suspected difficult airways defined as:
- •patients with an oropharyngeal score of 3 or 4
- •patients whose body mass index calculates greater to or equal to 35
排除标准
- •Patients who necessitate an awake fiberoptic intubation or a rapid sequence intubation.
结局指标
主要结局
Time Until Proper Endotracheal Tube Placement
时间窗: usually <100 seconds
Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.
次要结局
- Grade of Glottic View(<100 seconds)
- Lowest Pulse Oximetry Saturation Value Reading During Intubation(<100 seconds)
- Number of Participants With Successful Intubation(<100 seconds)
- Number of Attempts Performed During Airway Management(<100 seconds)
- Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist(<100 seconds)
- Alternate Device Used(<100 seconds)
研究者
Bret Alvis
Clinical Fellow
Vanderbilt University