Safety and Efficacy of the Tao Facemask for Positive Pressure Ventilation in the Patients With Significantly Elevated BMIs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Tao Scale Score
研究概览
简要总结
The Tao Mask is a new novel facemask for positive pressure ventilation which has recently been demonstrated (MUSC study Pro00047645) to have superior performance to our conventional (standard) positive pressure mask in a random distribution of patients with experiences users. This additional study will extend our investigation of the new masks capabilities by studying it's performance in the morbidly obese - which are more challenging patients to ventilate by mask. Our hypothesis is that the Tao mask will be even more effective in this challenging population than in the random distribution of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 是
入选标准
- •Age >18 years.
- •Patients having elective surgery (designated by priority level of 5) requiring general endotracheal anesthesia.
排除标准
- •Need for awake intubation based on standard preoperative evaluation by the attending anesthesiologist.
- •Increased risk for aspiration of gastric contents due to full stomach, pregnancy, gastro-esophageal reflux disease, and/or hiatal hernia as identified during the pre-operative assessment.
- •Previous tracheostomy procedure.
- •Patient is cognitively incapable of providing their consent for the study.
结局指标
主要结局
Tao Scale Score
时间窗: one year
The primary outcome will be the Tao Scale Score for each mask, compared between patients
次要结局
未报告次要终点
研究者
Carey Brewbaker
Assistant Professor Anesthesiology
Medical University of South Carolina