Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To compare the emitted small particle fraction between various respiratory activities.
研究概览
简要总结
In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give written informed consent.
- •Healthy male and female subjects, aged 18-80 years.
- •Body mass index between 18 and 35 kg/m
- •FEV1 ≥ 80% predicted.
排除标准
- •Any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
- •Risk of non-compliance with study procedures.
- •Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
- •History of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. In case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. Subjects must be asymptomatic for at least 3 days. Re-screening is allowed should the time window be exceeded.
- •History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis.
- •History of latex allergy.
结局指标
主要结局
To compare the emitted small particle fraction between various respiratory activities.
时间窗: Day 1, Day 2 to 14
Change of particle number per time unit between tidal breathing and various respiratory activities.
To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.
时间窗: After completion of Study part A (approximately 3 months)
Change of particle number per time unit between tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects.
次要结局
- To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.(After completion of Study part A (approximately 3 months))
- To assess the emitted particle size distribution of various respiratory activities.(Day 1, Day 2 to 14)
- To assess the reproducibility of exhaled particle quantification.(Day 2 to 14)