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

NCT04526925 | Terminated Results FDA Device

• 1 other identifier: CPET-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Transmission, Patient-Professional

Keywords

CardioPulmonary Exercise Testing; Aerosol Particle Size Distribution; Physiologic Responses; Filter

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• The Peak Heart Rate With and Without a Filter

  45 minutes

Study Arms (2)

standard CPET

ACTIVE COMPARATOR

Standard CPET will be performed without in-line filter

Other: Standard mouthpiece

standard CPET with in-line filter

EXPERIMENTAL

An in-line filter will be placed on the mouthpiece during standard CPET

Device: Respiratory filter in-line placed with the standard mouthpiece

Interventions

Respiratory filter in-line placed with the standard mouthpiece DEVICE

The respiratory filter is a device that removes solid/large particles from gas

standard CPET with in-line filter

Standard mouthpiece OTHER

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

standard CPET

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65, Male or Female
• Normal exercise tolerance without dyspnea or clinically important limitation of exercise tolerance.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• 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.

  PMID: 32299867 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.

  PMID: 32543913 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.

  PMID: 32479795 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.

  PMID: 32584237 BACKGROUND

Results Point of Contact

• Title: Jie Li
• Organization: Rush University

jie_li@rush.edu

3125634643

Study Officials

• Jie Li, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 26, 2020
• Study Start: August 29, 2020
• Primary Completion: September 18, 2020
• Study Completion: September 18, 2020
• Last Updated: April 26, 2023
• Results First Posted: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)