NCT04526925

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Transmission, Patient-Professional

Interventions

Type	Name	Description
DEVICE	Respiratory filter in-line placed with the standard mouthpiece	The respiratory filter is a device that removes solid/large particles from gas
OTHER	Standard mouthpiece	The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses

Timeline

• Start date: 2020-08-29
• Primary completion: 2020-09-18
• Completion: 2020-09-18
• First posted: 2020-08-26
• Last updated: 2023-04-26
• Results posted: 2023-04-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study