Transmission, Patient-ProfessionalNCT04526925

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

A study testing Respiratory filter in-line placed with the standard mouthpiece and Standard mouthpiece in people with Transmission, Patient-Professional, run by Rush University Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Transmission, Patient-Professional
What is being tested?: Respiratory filter in-line placed with the standard mouthpiece and Standard mouthpiece
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 29 Aug 2020to 18 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Transmission, Patient-Professional
Being tested: Respiratory filter in-line placed with the standard mouthpiece, Standard mouthpiece
Keywords: CardioPulmonary Exercise Testing, Aerosol Particle Size Distribution, Physiologic Responses, Filter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Respiratory filter in-line placed with the standard mouthpieceDevice
The respiratory filter is a device that removes solid/large particles from gas
Standard mouthpieceOther
The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses

Study groups in NCT04526925
Study group	Role	What they receive
standard CPET	Active comparator	Standard CPET will be performed without in-line filter Receives: Other: Standard mouthpiece
standard CPET with in-line filter	Experimental	An in-line filter will be placed on the mouthpiece during standard CPET Receives: Device: Respiratory filter in-line placed with the standard mouthpiece

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 45 minutes

Secondary outcomes (1)

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.
Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 202018 Sep 2020

First posted26 Aug 2020
Study start29 Aug 2020
Primary completion18 Sep 2020
Study completion18 Sep 2020

Why it stopped: Staffing issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Transmission, Patient-ProfessionalStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04526925
Sponsor's protocol ID: CPET-001
Status last verified: Apr 2023
First submitted: 21 Aug 2020
Last updated: 26 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No data will be shared

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.
PubMed 32299867
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.
PubMed 32543913
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.
PubMed 32479795
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.
PubMed 32584237

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Physiologic Research to Assess the Effect of an Inline Filter During Cardiopulmonary Exercise Testing (CPET): A Healthy Volunteer Study
ClinicalTrials.gov ID: NCT04526925
Acronym / sponsor ID: CPET-001
Conditions: Transmission, Patient-Professional
Keywords: CardioPulmonary Exercise Testing, Aerosol Particle Size Distribution, Physiologic Responses, Filter
Study type: Interventional
Recruitment status: TerminatedReason stopped: Staffing issues
Enrolment: 10 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Collaborators: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study start: 29 Aug 2020 (actual)
Primary completion: 18 Sep 2020 (actual)
Study completion: 18 Sep 2020 (actual)
First posted: 26 Aug 2020 (actual)
Results: Posted 26 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
standard CPET	Active comparator	Other: Standard mouthpieceStandard CPET will be performed without in-line filter
standard CPET with in-line filter	Experimental	Device: Respiratory filter in-line placed with the standard mouthpieceAn in-line filter will be placed on the mouthpiece during standard CPET

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

Complicated heart or lung disease
Pregnancy
Complex arrhythmias
Severe Anemia
Uncontrolled Diabetes, hypertension, or untreated thyroid disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Respiratory filter in-line placed with the standard mouthpieceThe respiratory filter is a device that removes solid/large particles from gas	Device	standard CPET with in-line filter
Standard mouthpieceThe mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses	Other	standard CPET

Primary outcome

The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter
Time frame: 45 minutes
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.
The Peak Minute Ventilation With and Without a Filter
Time frame: 45 minutes
During CPET, participants' breathing volume (minute ventilation) is continuously monitored. The peak minute ventilation with and without a filter is reported.
The Peak Oxygen Uptake With and Without a Filter
Time frame: 45 minutes
During CPET, participants' oxygen consumption (namely, oxygen uptake) is continuously monitored. The peak oxygen uptake with and without an inline filter are reported.
The Peak Carbon Dioxide Output With and Without a Filter
Time frame: 45 minutes
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.

1 secondary outcome

The Peak Heart Rate With and Without a Filter
Time frame: 45 minutes

Results and safety

Results posted to the registry on 26 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CPET Without a Filter First Then CPET With a Filter	4	4
CPET With a Filter First Then CPET Without a Filter	6	6

Primary outcome: The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter

Time frame: 45 minutes. Mean (Standard Deviation). Unit: particles per cubic centimeters

Measure	Standard CPET n = 10	Standard CPET With In-line Filter n = 10
Value	204.3 (50.6)	197.1 (4.6)

Primary outcome: The Peak Minute Ventilation With and Without a Filter

Time frame: 45 minutes. Mean (Standard Deviation). Unit: liter per minute

Measure	Standard CPET n = 10	Standard CPET With In-line Filter n = 10
Value	86.1 (22.7)	88.1 (21.8)

Primary outcome: The Peak Oxygen Uptake With and Without a Filter

Time frame: 45 minutes. Mean (Standard Deviation). Unit: liter per minute

Measure	Standard CPET n = 10	Standard CPET With In-line Filter n = 10
Value	2.37 (0.75)	2.42 (0.75)

Primary outcome: The Peak Carbon Dioxide Output With and Without a Filter

Time frame: 45 minutes. Mean (Standard Deviation). Unit: liter per minute

Measure	Standard CPET n = 10	Standard CPET With In-line Filter n = 10
Value	2.84 (0.85)	2.80 (0.80)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 hour. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard CPET	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Standard CPET With In-line Filter	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32299867Li 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.
Background: PubMed 32543913Dhand 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.
Background: PubMed 32479795Hull 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.
Background: PubMed 32584237Gemicioglu 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.
Individual participant dataSharing planned: No. No data will be shared

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jie Li, PhD principal investigator

Rush University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Peak Aerosol Particle Concentrations During CPET With a Filter and Without a Filter (time frame: 45 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04526925, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.