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| Name | Class |
|---|---|
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard CPET | Active Comparator | Standard CPET will be performed without in-line filter |
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| standard CPET with in-line filter | Experimental | An in-line filter will be placed on the mouthpiece during standard CPET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory filter in-line placed with the standard mouthpiece | Device | The respiratory filter is a device that removes solid/large particles from gas |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter | 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. | 45 minutes |
| The Peak Minute Ventilation With and Without a Filter | During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported. | 45 minutes |
| The Peak Oxygen Uptake With and Without a Filter | During CPET, participants' oxygen consumption (namely, oxygen uptake) is continuously monitored. The peak oxygen uptake with and without an inline filter are reported. | 45 minutes |
| The Peak Carbon Dioxide Output With and Without a Filter | 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. | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The Peak Heart Rate With and Without a Filter | During CPET, patients' heart rate is continuously monitored, and the peak heart rate with and without an inline filter are reported. | 45 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Li, PhD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32299867 | Background | Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May. | |
| 32543913 | Background | Dhand R, Li J. Coughs and Sneezes: Their Role in Transmission of Respiratory Viral Infections, Including SARS-CoV-2. Am J Respir Crit Care Med. 2020 Sep 1;202(5):651-659. doi: 10.1164/rccm.202004-1263PP. No abstract available. |
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No data will be shared
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | CPET With a Filter First Then CPET Without a Filter |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter | 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. | Posted | Mean | Standard Deviation | particles per cubic centimeters | 45 minutes |
|
1 hour
Cardiac arrest or death
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard CPET | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jie Li | Rush University | 3125634643 | jie_li@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2020 | Oct 30, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 17, 2020 | Oct 30, 2022 | ICF_001.pdf |
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| Standard mouthpiece | Other | The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses |
|
| 32479795 | Background | Hull JH, Lloyd JK, Cooper BG. Lung function testing in the COVID-19 endemic. Lancet Respir Med. 2020 Jul;8(7):666-667. doi: 10.1016/S2213-2600(20)30246-0. Epub 2020 May 29. No abstract available. |
| 32584237 | Background | Gemicioglu B, Borekci S, Dilektasli AG, Ulubay G, Azap O, Saryal S. Turkish Thoracic Society Experts Consensus Report: Recommendations for Pulmonary Function Tests During and After COVID 19 Pandemic. Turk Thorac J. 2020 May;21(3):193-200. doi: 10.5152/TurkThoracJ.2020.20107. |
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Standard CPET will be performed with an inline filter first then CPET will be performed without an inline filter.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Standard CPET With In-line Filter |
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 |
|
|
| Primary | The Peak Minute Ventilation With and Without a Filter | During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported. | Posted | Mean | Standard Deviation | liter per minute | 45 minutes |
|
|
|
| Primary | The Peak Oxygen Uptake With and Without a Filter | During CPET, participants' oxygen consumption (namely, oxygen uptake) is continuously monitored. The peak oxygen uptake with and without an inline filter are reported. | Posted | Mean | Standard Deviation | liter per minute | 45 minutes |
|
|
|
| Primary | The Peak Carbon Dioxide Output With and Without a Filter | 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. | Posted | Mean | Standard Deviation | liter per minute | 45 minutes |
|
|
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| Secondary | The Peak Heart Rate With and Without a Filter | During CPET, patients' heart rate is continuously monitored, and the peak heart rate with and without an inline filter are reported. | Posted | Mean | Standard Deviation | beats per minute | 45 minutes |
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| 0 |
| 10 |
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| 10 |
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| 10 |
| EG001 | Standard CPET With In-line Filter | 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 | 0 | 10 | 0 | 10 | 0 | 10 |
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