Use of Stable Airway Management Device in Monitored Anesthesia Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total Apneic Events /Total Number Requiring Airway Manipulation
研究概览
简要总结
The aim of this study is to determine if the Stable Airway Management device (SAM) is safe in maintaining the airway in a stable, non-obstructing position during anesthetic cases requiring monitored anesthesia care (MAC).
详细描述
Patients undergoing monitored anesthesia care as part of a procedure will be invited to participate in the study.
The stable airway management (SAM) device is an investigational device used to hold patient's head and airway in a stable position during a MAC procedure. An investigational device means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, the SAM will be compared to the standard of anesthesia care which consists of supporting patient's head, neck, and shoulders with pillows and towels when placing them in the correct position for the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 undergoing MAC anesthesia in the supine position
- •Patients able to give informed consent
排除标准
- •Age < 18 years
- •Less than 88% oxygen saturation on room air
- •Non-elective procedures
- •Case duration > 180 minutes
- •Presence of a cervical spine injury, instability, or cervical spine collar
- •Patients with airway, facial, or other anatomy deemed inappropriate for SAM use by anesthesiologist
- •General anesthesia as primary anesthetic
- •Pregnant women
结局指标
主要结局
Total Apneic Events /Total Number Requiring Airway Manipulation
时间窗: Up to 6 hours
total number of apneic events greater than 20 seconds per 15-minute intervals, requiring airway manipulation - The median value of airway manipulations will be reported for each arm, along with the range of manipulations (low-high) for each study arm will be reported.
Number of Subjects Converted From MAC to General Anesthesia
时间窗: Up to 6 hours
Number of participants converted from MAC to general anesthesia for airway-related complications
次要结局
未报告次要终点