A Physiologic Research to Assess the Effect of an Inline Filter During Cardiopulmonary Exercise Testing (CPET): A Healthy Volunteer Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter
研究概览
简要总结
Due to the concerns of virus transmission during COVID-19 pandemic, multiple respiratory societies postpone or limit pulmonary function test, especially cardiopulmonary exercise test (CPET), as patients may generate large amount of aerosol particles during test but it is conventionally performed without filter. This study aims to investigate the effects of reducing aerosol particle concentrations in the room air during CPET by placing an inline filter, and to assess the effects of filter on the physiologic responses during CPET.
详细描述
The subject will spend two visits one hour each day (~ 1 hour) in the PFT lab and will have two separate CPET (Vmax Encore PFT System, Vyaire medical, Mettawa, IL) tests performed by registered pulmonary function technologists. One day the test will be performed with the inline filter during CPET, and the second day the CPET will be performed without a filter. During the test, electrocardiogram (ECG) electrodes will be attached to participants as well as a mask, and their heart rate will be measured for 10 minutes at rest, and then they will ride bicycle for 20 minutes at different levels of intensity. The work rate increment will be the same for both tests. All gas exchange and aerosol particle concentrations measures will be compared with Bland Altman analysis and paired t-testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •Normal exercise tolerance without dyspnea or clinically important limitation of exercise tolerance.
排除标准
- •Complicated heart or lung disease
- •Pregnancy
- •Complex arrhythmias
- •Severe Anemia
- •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.
- •Any Disease that the PI feels will markedly increase the risk of CPET testing
研究组 & 干预措施
standard CPET
Standard CPET will be performed without in-line filter
干预措施: Standard mouthpiece (Other)
standard CPET with in-line filter
An in-line filter will be placed on the mouthpiece during standard CPET
干预措施: Respiratory filter in-line placed with the standard mouthpiece (Device)
结局指标
主要结局
The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter
时间窗: 45 minutes
The peak aerosol particle concentrations between the situations with and without an in-line filter are reported. The peak concentrations of aerosol particles generated by subjects during CPET, are measured as particles per cubic centimeters of room air. The device measured the concentrations every 6 seconds, it continuously recorded the data for 45 minutes since CPET started and peak concentrations were reported.
The Peak Minute Ventilation With and Without a Filter
时间窗: 45 minutes
During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported.
The Peak Oxygen Uptake With and Without a Filter
时间窗: 45 minutes
During CPET, participants' oxygen consumption (namely, oxygen uptake) is continuously monitored. The peak oxygen uptake with and without an inline filter are reported.
The Peak Carbon Dioxide Output With and Without a Filter
时间窗: 45 minutes
During CPET, participants' exhaled volume of carbon dioxide (CO2) (namely, CO2 output) is continuously monitored. The peak CO2 output with and without an inline filter are reported.
次要结局
- The Peak Heart Rate With and Without a Filter(45 minutes)