Trial Outcomes & Findings for The Effects of Filter During CPET on WOB and Aerosol Particle Concentrations (NCT NCT04526925)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

45 minutes

Results posted on

2023-04-26

Participant Flow

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.

Participant milestones

Participant milestones
Measure	CPET Without a Filter First Then CPET With a Filter Standard CPET will be performed without an in-line filter first then CPET will be performed with an in-line filter The filter is connected to the mouthpiece during CPET	CPET With a Filter First Then CPET Without a Filter Standard CPET will be performed with an in-line filter first then CPET will be performed without an in-line filter
First Intervention STARTED	4	6
First Intervention COMPLETED	4	6
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	4	6
Second Intervention COMPLETED	4	6
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPET Without a Filter First Then CPET With a Filter n=4 Participants Standard CPET will be performed without an inline filter first then CPET will be performed with an inline filter.	CPET With a Filter First Then CPET Without a Filter n=6 Participants Standard CPET will be performed with an inline filter first then CPET will be performed without an inline filter.	Total n=10 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 7.4 • n=5 Participants	32.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	32.4 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard CPET n=10 Participants Standard CPET will be performed without in-line filter Standard mouthpiece: 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 n=10 Participants An in-line filter will be placed on the mouthpiece during standard CPET Respiratory filter in-line placed with the standard mouthpiece: The respiratory filter is a device that removes solid/large particles from gas
The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter	204.3 particles per cubic centimeters Standard Deviation 50.6	197.1 particles per cubic centimeters Standard Deviation 4.6

PRIMARY outcome

Timeframe: 45 minutes

During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported.

Outcome measures

Outcome measures
Measure	Standard CPET n=10 Participants Standard CPET will be performed without in-line filter Standard mouthpiece: 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 n=10 Participants An in-line filter will be placed on the mouthpiece during standard CPET Respiratory filter in-line placed with the standard mouthpiece: The respiratory filter is a device that removes solid/large particles from gas
The Peak Minute Ventilation With and Without a Filter	86.1 liter per minute Standard Deviation 22.7	88.1 liter per minute Standard Deviation 21.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard CPET n=10 Participants Standard CPET will be performed without in-line filter Standard mouthpiece: 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 n=10 Participants An in-line filter will be placed on the mouthpiece during standard CPET Respiratory filter in-line placed with the standard mouthpiece: The respiratory filter is a device that removes solid/large particles from gas
The Peak Oxygen Uptake With and Without a Filter	2.37 liter per minute Standard Deviation 0.75	2.42 liter per minute Standard Deviation 0.75

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard CPET n=10 Participants Standard CPET will be performed without in-line filter Standard mouthpiece: 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 n=10 Participants An in-line filter will be placed on the mouthpiece during standard CPET Respiratory filter in-line placed with the standard mouthpiece: The respiratory filter is a device that removes solid/large particles from gas
The Peak Carbon Dioxide Output With and Without a Filter	2.84 liter per minute Standard Deviation 0.85	2.80 liter per minute Standard Deviation 0.80

SECONDARY outcome

Timeframe: 45 minutes

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

Outcome measures

Outcome measures
Measure	Standard CPET n=10 Participants Standard CPET will be performed without in-line filter Standard mouthpiece: 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 n=10 Participants An in-line filter will be placed on the mouthpiece during standard CPET Respiratory filter in-line placed with the standard mouthpiece: The respiratory filter is a device that removes solid/large particles from gas
The Peak Heart Rate With and Without a Filter	164.7 beats per minute Standard Deviation 11.1	167.1 beats per minute Standard Deviation 9.2

Adverse Events

Standard CPET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard CPET With In-line Filter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jie Li

Rush University

Phone: 3125634643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place