Comparison of Endotracheal Intubation Over the Aintree Via the I-gel and Laryngeal Mask Airway Supreme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Time to Successful Tracheal Intubation
研究概览
简要总结
The investigators plan to conduct a randomized trial comparing the efficacy of intubating the tracheal using an Aintree intubation catheter through either the LMA-S or I-gel supraglottic devices
详细描述
With the proposal, the investigators are comparing two different types of supraglottic devices. One is the LMA Supreme (laryngeal mask airway) and the other is the I-gel. The study is designed to use the supraglottic airway device as an adjunct to tracheal intubation, not as the definitive airway. The investigators will be utilizing the Aintree intubation catheter over the fiberoptic bronchoscope in an effort to secure the airway. This technique has been well described in the literature and has been proven effective and safe.
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
- 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
- •Subjects that will require routine endotracheal intubation for general anesthesia as part of their surgery.
- •Age >18 years old.
- •Can provide informed consent.
排除标准
- •Subjects that require rapid sequence induction for endotracheal intubation; i.e., parturients, or any subject that is at high risk for aspirating gastric contents into the airway.
- •Subjects that have an allergy to Propofol or eggs.
- •Subjects that have an allergy to rocuronium.
- •Subjects with a history of oropharyngeal or laryngeal surgery, or subjects undergoing oropharyngeal or laryngeal surgery.
- •Subjects with congenital or anatomical airway anomalies.
- •Subjects with anticipated reduced functional residual capacity as predicted by a body mass index ≥
- •Currently enrolled in another research study.
研究组 & 干预措施
LMA-Supreme supraglottic device
The LMA-Supreme is a single-use disposable supraglottic airway that utilizes an inflatable cuff
干预措施: LMA-Supreme supraglottic device (Device)
I-gel supraglottic device
The I-gel is an alternative supraglottic device made from thermoplastic elastomer which provides the seal over the airway versus an inflatable cuff.
干预措施: I-gel supraglottic device (Device)
结局指标
主要结局
Time to Successful Tracheal Intubation
时间窗: Up to 10 minutes
This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.
次要结局
- Time to Placement of the Supra Glottic Device(Up to 10 minutes)
- Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device(Up to 10 minutes)
- Time to Placement of the Aintree Airway Intubation Catheter(Up to 10 minutes)
- Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.(Up to 10 minutes)
- Time to Placement of the Endotrotracheal Tube(Up to 10 minutes)
- Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube(Up to 10 minutes)
研究者
Antonio Hernandez
Assoc Professor of Clinical Anesthesiology
Vanderbilt University