Biocontainment Device With Aerosol Clearance for Aerosol Generating Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
研究概览
简要总结
The primary goal of this study is to assess use of a biocontainment device for planned airway procedures under general anesthesia. This will serve as a platform for using this device as a novel biocontainment and aerosol evacuation system as part of rapid sequence intubation protocols for COVID-19 patients. We hypothesize that airway procedures with the aerosol biocontainment device will be safe and effective with airway procedure times approaching times for airway procedures without the device.
详细描述
This is a multi-site (two sites), unblinded, randomized, observational study performed in a controlled environment in the operating room. The hypothesis is that rapid sequence intubation or other urgent airway procedures performed with the biocontainment device will be safe and can be performed in an equivalent manner to urgent airway procedures without the biocontainment device. Methods to minimize bias include randomizing patients to intubation with or without the biocontainment device.
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
- •A) User (healthcare worker):
- •Anesthesiologist, anesthesia resident, or CRNA at the Hospital of the University of Pennsylvania or PPMC who has signed and dated informed consent.
- •B) Patient:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •ASA I, II, III
- •Undergoing planned procedure involving an airway procedure under general anesthesia
排除标准
- •A) User (healthcare worker):
- •Pregnancy due to potential risks from lifting the device.
- •B) Patient:
- •Known history of difficult airway
- •Anticipated difficult airway management for any reason
- •COVID-19 positive status
- •Pregnancy
- •Planned prolonged intubation post-surgery or anticipated inability to answer patient questionnaire within 1 week of intubation.
结局指标
主要结局
Measuring the Time for Performing an Airway Procedure With or Without the Biocontainment Device.
时间窗: Start of airway procedure through to completion of airway procedure.
Measure the amount of time it take to perform an airway procedure (intubation) with or without the biocontainment device.
Quantifying the Number of AEs or ADEs to Assess Device Safety.
时间窗: collected at time of procedure, on average within 3 minutes of starting the procedure
Measure the number of adverse events, adverse device events associated with using the biocontainment device.
次要结局
- Median Likert Ratings From Device Use Survey Questions That Assess User Subject Device Comfort.(Survey completed up to 1 day after airway procedure)
- Median Likert Rating of the Patient Questionnaire Results to Assess Patient Experience in the Device.(Survey completed up to 1 day after airway procedure)
- Median Likert Ratings From Device Use Survey Questions That Assess User Subject Healthcare Burden With the Device.(Survey completed up to 1 day after completion of airway procedure)