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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04526925

Enrollment

Registered

2020-08-26

Start date

2020-08-29

Completion date

2020-09-18

Last updated

2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transmission, Patient-Professional

Keywords

CardioPulmonary Exercise Testing, Aerosol Particle Size Distribution, Physiologic Responses, Filter

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.

Interventions

DEVICERespiratory filter in-line placed with the standard mouthpiece

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

OTHERStandard mouthpiece

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter	45 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 Filter	45 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 Filter	45 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 Filter	45 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

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

Countries

United States

Participant flow

Recruitment details

This is a randomized crossover study, all the 10 participants performed cardiopulmonary exercise test (CPET). During the test, they will be randomly assigned to Standard CPET Without Filter first, then Standard CPET With Filter, or Standard CPET With Filter first, then Standard CPET Without Filter. The time period between two tests were 48 hours.

Participants by arm

Arm	Count
CPET Without a Filter First Then CPET With a Filter Standard CPET will be performed without an inline filter first then CPET will be performed with an inline filter.	4
CPET With a Filter First Then CPET Without a Filter Standard CPET will be performed with an inline filter first then CPET will be performed without an inline filter.	6
Total	10

Baseline characteristics

Characteristic	CPET Without a Filter First Then CPET With a Filter	CPET With a Filter First Then CPET Without a Filter	Total
Age, Continuous	31.8 years STANDARD_DEVIATION 7.4	32.8 years STANDARD_DEVIATION 9.2	32.4 years STANDARD_DEVIATION 8.1
Race/Ethnicity, Customized Asian	2 Participants	2 Participants	4 Participants
Race/Ethnicity, Customized Caucasian	2 Participants	3 Participants	5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants	1 Participants	1 Participants
Sex: Female, Male Female	2 Participants	3 Participants	5 Participants
Sex: Female, Male Male	2 Participants	3 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 10	0 / 10
other Total, other adverse events	0 / 10	0 / 10
serious Total, serious adverse events	0 / 10	0 / 10

Arm	Measure	Value (MEAN)	Dispersion
Standard CPET	The Peak Heart Rate With and Without a Filter	164.7 beats per minute	Standard Deviation 11.1
Standard CPET With In-line Filter	The Peak Heart Rate With and Without a Filter	167.1 beats per minute	Standard Deviation 9.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026