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

Not Applicable
Terminated
Conditions
Transmission, Patient-Professional
Interventions
Device: Respiratory filter in-line placed with the standard mouthpiece
Other: Standard mouthpiece
Registration Number
NCT04526925
Lead Sponsor
Rush University Medical Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
10
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
standard CPET with in-line filterRespiratory filter in-line placed with the standard mouthpieceAn in-line filter will be placed on the mouthpiece during standard CPET
standard CPETStandard mouthpieceStandard CPET will be performed without in-line filter
Primary Outcome Measures
NameTimeMethod
The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter45 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 Filter45 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 Filter45 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 Filter45 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.

Secondary Outcome Measures
NameTimeMethod
The Peak Heart Rate With and Without a Filter45 minutes

During CPET, patients' heart rate is continuously monitored, and the peak heart rate with and without an inline filter are reported.

Trial Locations

Locations (1)

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

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