The Effects of Filter During CPET on WOB and Aerosol Particle Concentrations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Physiologic Research to Assess the Effect of an Inline Filter During Cardiopulmonary Exercise Testing (CPET): A Healthy Volunteer Study

Conditions
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Transmission, Patient-Professional

Intervention / Treatment
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* Device: Respiratory filter in-line placed with the standard mouthpiece
* Other: Standard mouthpiece


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-65, Male or Female Normal exercise tolerance without dyspnea or clinically important limitation of exercise tolerance. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard CPET<br>Standard CPET will be performed without in-line filter | Other: Standard mouthpiece<br>* The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses<br>|
| Experimental: standard CPET with in-line filter<br>An in-line filter will be placed on the mouthpiece during standard CPET | Device: Respiratory filter in-line placed with the standard mouthpiece<br>* The respiratory filter is a device that removes solid/large particles from gas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter | 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. | 45 minutes | 
| The Peak Minute Ventilation With and Without a Filter | During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported. | 45 minutes | 
| The Peak Oxygen Uptake With and Without a Filter | During CPET, participants' oxygen consumption (namely, oxygen uptake) is continuously monitored. The peak oxygen uptake with and without an inline filter are reported. | 45 minutes | 
| The Peak Carbon Dioxide Output With and Without a Filter | 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. | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Peak Heart Rate With and Without a Filter | During CPET, patients' heart rate is continuously monitored, and the peak heart rate with and without an inline filter are reported. | 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CardioPulmonary Exercise Testing, Aerosol Particle Size Distribution, Physiologic Responses, Filter