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

Transmission, Patient-Professional Clinical Trial

Official title:

A Physiologic Research to Assess the Effect of an Inline Filter During Cardiopulmonary Exercise Testing (CPET): A Healthy Volunteer Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04526925
• Other study ID #: CPET-001
• Status: Terminated
• Phase: N/A
• Start date: August 29, 2020
• Est. completion date: September 18, 2020

Study information

• Verified date: April 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 18, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Transmission, Patient-Professional

Intervention

Device:
• Respiratory filter in-line placed with the standard mouthpiece
The respiratory filter is a device that removes solid/large particles from gas

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

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	45 minutes
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.	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.	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.	45 minutes
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.	45 minutes