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临床试验/NCT04681599
NCT04681599已完成不适用

Comparison of Different Modalities in Reducing Airborne Particulate Concentrations During Aerosol Generating Procedures for Health Volunteers: a Randomized Cross-over Trial

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
aerosol particle concentrations at 1 foot away from subject's face

研究概览

简要总结

Several clinical procedures have been described as aerosol generating procedure (AGP), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. However, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. This study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Ages 18-65, Male or Female

排除标准

  • •Chronic lung disease, including asthma, COPD, etc.
  • •Upper airway anatomical abnormities
  • •Pregnancy
  • •Uncontrolled Diabetes, hypertension, or untreated thyroid disease
  • •Has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit.
  • •COVID-19 test positive within 21 days.

研究组 & 干预措施

Nebulization without filter or scavenger

No Intervention

Subject will use a standard nebulizer

Nebulization with a filter or scavenger

Experimental

Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask

干预措施: Filter (Device)

Nebulization with a filter or scavenger

Experimental

Subject will use a nebulizer with a filter placed at the other end of nebulizer mouthpice or a scavenger outside the nebulizer mask

干预措施: Scavenger face tent (Device)

High-flow nasal cannula

No Intervention

Subject will use high-flow nasal cannula at 40 L/min

High-flow nasal cannula with a scavenger face tent

Experimental

Subject will use high-flow nasal cannula at 40 L/min, with a scavenger face tent

干预措施: Scavenger face tent (Device)

High-flow nasal cannula with a surgical mask

Active Comparator

Subject will use high-flow nasal cannula at 40 L/min, with a surgical mask over nasal cannula

干预措施: Filter (Device)

结局指标

主要结局

aerosol particle concentrations at 1 foot away from subject's face

时间窗: 5 mins

aerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 1 foot away from subject's face

aerosol particle concentrations at 3 feet away from subject's face

时间窗: 5 mins

aerosol particle concentrations will be recorded continuously for 5 mins during the use of each device at 3 feet away from subject's face

次要结局

  • subject's comfort(5 minutes after using the device)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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