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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-29

Study Completion Date

2020-09-18

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.

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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.

Conditions

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Transmission, Patient-Professional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard CPET

Standard CPET will be performed without in-line filter

Group Type ACTIVE_COMPARATOR

Standard mouthpiece

Intervention Type OTHER

The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses

standard CPET with in-line filter

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

Group Type EXPERIMENTAL

Respiratory filter in-line placed with the standard mouthpiece

Intervention Type DEVICE

The respiratory filter is a device that removes solid/large particles from gas

Interventions

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Respiratory filter in-line placed with the standard mouthpiece

The respiratory filter is a device that removes solid/large particles from gas

Intervention Type DEVICE

Standard mouthpiece

The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes