Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Aerosolization of Particles During Upper Endoscopy
研究概览
简要总结
Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.
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
- •All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.
排除标准
- •Any patient requiring endotracheal intubation
- •Pregnant patients
- •Emergency procedures
- •Patients who require use of a facemask before or during the procedure due to medical necessity
- •Patients under the age of 18
- •Non-English speaking individuals
- •Patients unable to provide consent.
- •Any procedure done outside the designated procedure room.
- •If in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study
研究组 & 干预措施
Endoscopic Facemask
Patients undergoing endoscopy with the use of an endoscopic facemask
干预措施: Endoscopic Patient Facemask (Device)
No Endoscopic Facemask
Patients undergoing endoscopy without an endoscopic facemask
结局指标
主要结局
Aerosolization of Particles During Upper Endoscopy
时间窗: Start of endoscopy through the end of endoscopy
Comparing the aerosolization of particles of six different sizes \[0.3μm, 0.5μm, 1μm, 2μm, 5μm and 10μm\] during endoscopy between patients using an endoscopic facemask to those without.
次要结局
未报告次要终点