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

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.

Study Overview

• Status: Terminated
• Conditions: Transmission, Patient-Professional
• Intervention / Treatment: Other: Standard mouthpiece; Device: Respiratory filter in-line placed with the standard mouthpiece

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard CPET; Standard CPET will be performed without in-line filter	Other: Standard mouthpiece; The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses
Experimental: standard CPET with in-line filter; An in-line filter will be placed on the mouthpiece during standard CPET	Device: Respiratory filter in-line placed with the standard mouthpiece; The respiratory filter is a device that removes solid/large particles from gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Investigators: Principal Investigator: Jie Li, PhD, Rush University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2020
• Primary Completion (Actual): September 18, 2020
• Study Completion (Actual): September 18, 2020

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Filter; CardioPulmonary Exercise Testing; Aerosol Particle Size Distribution; Physiologic Responses
• Other Study ID Numbers: CPET-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No