Clinical trial NCT04526925: The Effects of Filter During CPET on WOB and Aerosol Particle Concentrations
Official title: A Physiologic Research to Assess the Effect of an Inline Filter During Cardiopulmonary Exercise Testing (CPET): A Healthy Volunteer Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transmission, Patient-Professional
Keywords: CardioPulmonary Exercise Testing
Aerosol Particle Size Distribution
Physiologic Responses
Filter
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
First posted: 2020-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter
timeFrame: 45 minutes
measure: The Peak Minute Ventilation With and Without a Filter
timeFrame: 45 minutes
measure: The Peak Oxygen Uptake With and Without a Filter
timeFrame: 45 minutes
measure: The Peak Carbon Dioxide Output With and Without a Filter
timeFrame: 45 minutes
Secondary outcomes:
measure: The Peak Heart Rate With and Without a Filter
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.