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

Rush

Status: Terminated

Conditions: Transmission, Patient-Professional

Treatments: Other: Standard mouthpiece; Device: Respiratory filter in-line placed with the standard mouthpiece

Study type: Interventional

Funder types: Other

Identifiers

NCT04526925

CPET-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

standard CPET

Active Comparator group

Description:

Standard CPET will be performed without in-line filter

Treatment:

Other: Standard mouthpiece

standard CPET with in-line filter

Experimental group

Description:

An in-line filter will be placed on the mouthpiece during standard CPET

Treatment:

Device: Respiratory filter in-line placed with the standard mouthpiece