CopdNCT05913323

Measuring Lung Mechanics in Patients with COPD Using the REOM Handheld Portable Device

An observational study of Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose the study is to determine the agreement between the information obtained about lung mechanics (lung function) from the Rapid Expiratory Occlusion Monitor (REOM) handheld portable device with that obtained by conventional oscillometry as well as by pulmonary function testing (PFT), in patients with both… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Copd
What is being tested?: Rapid Expiratory Occlusion Monitor (REOM), Standard oscillometry and Standard pulmonary function test
Type of treatment: Medical device
How many people: 17 participants
Where: 1 siteCanada
Study dates: 1 Aug 2023to 6 Aug 2024
Phase: Observational
Are there results?: None posted in the registry

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with COPD at the Montreal Chest Institute (MCI) of the McGill University Health Centre (MUHC).

Who may be able to join

Males and females aged ≥40 with COPD, former/current smokers with a ≥10 pack-year smoking history.
Diagnosed with COPD by FEV1/FVC < 0.7 using standard PFT post-bronchodilator testing, with either 'mild' ('GOLD 1': FEV1 ≥ 80% of predicted value) COPD or 'very severe' ('GOLD 4': FEV1 < 30% of predicted value) COPD.
Ability to provide informed consent.

Who cannot join

No existing COPD diagnosis
History of co-morbid asthma
Current use of home oxygen
Any acute exacerbation of COPD (AECOPD) experienced within 4 weeks of participation in the study
Chronic respiratory infection
Any contraindication to respiratory testing
Inability to participate in reproducible measurements due to physical or cognitive barrier

Trial locations and contacts

1 site in 1 country.

Canada1 site

McGill University Health Centre
Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: Measuring Lung Mechanics in Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the Rapid Expiratory Occlusion Method (REOM) Handheld Portable Oscillometer: a Cross-Sectional Study.

Read the detailed description

The primary objective of this cross-sectional study is to determine the concordance and agreement between the parameters obtained from the REOM, Reo1 and Reo2, and the conventional resistance parameters obtained by the tremoflo oscillometer device (R19 and R5, respectively) in adults with COPD confirmed by diagnostic pulmonary function testing (PFT).

The secondary objectives are:

To investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD.
To collect descriptive information on the participant user experience with the REOM.
To determine concordance between the parameters obtained from the REOM and those obtained from the tremoflo oscillometry device with the 'standard' parameters obtained from each participant's standard Pulmonary Function Tests (PFT).

Hypothesis:

We hypothesize in the adult COPD patient population that the REOM parameter Reo1 and tremoflo device parameter R19 will correlate closely, and that the REOM parameter Reo2 and tremoflo device parameter R5 will correlate closely. We also hypothesize that the REOM, in particular, Reo2, will be able to distinguish between 'mild' and 'very severe' COPD, and that participants will report a positive user experience with the REOM.

Conditions: Copd
Being tested: Rapid Expiratory Occlusion Monitor (REOM), Standard oscillometry, Standard pulmonary function test
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

Rapid Expiratory Occlusion Monitor (REOM)Device
Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.
Standard oscillometryDiagnostic test
tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada
Standard pulmonary function testDiagnostic test
Standard-of-care respiratory test.

Study groups in NCT05913323
Study group	Role	What they receive
COPD sub-group: GOLD 1 COPD		A secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'mild' (GOLD 1) COPD sub-group. Receives: Device: Rapid Expiratory Occlusion Monitor (REOM); Diagnostic Test: Standard oscillometry; Diagnostic Test: Standard pulmonary function test
COPD sub-group: GOLD 4 COPD		A secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'very severe' (GOLD 4) COPD sub-group. Receives: Device: Rapid Expiratory Occlusion Monitor (REOM); Diagnostic Test: Standard oscillometry; Diagnostic Test: Standard pulmonary function test

What is being measured

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

Concordance (correlation)
Correlation will be tested using the Spearman correlation coefficient (r) between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.
Measured: Single-visit study: all tests performed at one single visit.
Agreement
Agreement will be tested using the Bland-Altman test between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.
Measured: Single-visit study: all tests performed at one single visit.

Secondary outcomes (2)

Discriminative capacity
The t-test (between 2 independent means) will be used to determine the discriminative capacity of the REOM to distinguish between 'mild' and 'very severe' COPD.
Measured: Single-visit study: all tests performed at one single visit.
Participant satisfaction and usability experience
Each participant will complete a 'participant satisfaction questionnaire' as well as the validated System Usability Scale (SUS) for each test (REOM, standard oscillometry, pulmonary function test). Data will be presented descriptively.
Measured: Single-visit study: all tests performed at one single visit.

Timeline

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

1 Aug 20236 Aug 2024

First posted22 Jun 2023
Study start1 Aug 2023
Primary completion6 Aug 2024
Study completion6 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CopdStudies of the same condition, open and under way.
More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05913323
Sponsor's protocol ID: 2023-9001
Status last verified: Sep 2024
First submitted: 13 Jun 2023
Last updated: 26 Sep 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis

All Copd trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Lung Mechanics in Patients with Chronic Obstructive Pulmonary Disease (COPD) Using the Rapid Expiratory Occlusion Method (REOM) Handheld Portable Oscillometer: a Cross-Sectional Study.
ClinicalTrials.gov ID: NCT05913323
Acronym / sponsor ID: 2023-9001
Conditions: Copd
Study type: Observational
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Collaborators: McGill University, Thorasys Thoracic Medical Systems Inc.
Study start: 1 Aug 2023 (actual)
Primary completion: 6 Aug 2024 (actual)
Study completion: 6 Aug 2024 (actual)
First posted: 22 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The secondary objectives are:

To investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD.
To collect descriptive information on the participant user experience with the REOM.
To determine concordance between the parameters obtained from the REOM and those obtained from the tremoflo oscillometry device with the 'standard' parameters obtained from each participant's standard Pulmonary Function Tests (PFT).

Hypothesis:

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
COPD sub-group: GOLD 1 COPD	–	Device: Rapid Expiratory Occlusion Monitor (REOM), Diagnostic Test: Standard oscillometry, Diagnostic Test: Standard pulmonary function testA secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'mild' (GOLD 1) COPD sub-group.
COPD sub-group: GOLD 4 COPD	–	Device: Rapid Expiratory Occlusion Monitor (REOM), Diagnostic Test: Standard oscillometry, Diagnostic Test: Standard pulmonary function testA secondary objective of the study is to investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD. Thus, there will be a 'very severe' (GOLD 4) COPD sub-group.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with COPD at the Montreal Chest Institute (MCI) of the McGill University Health Centre (MUHC).

Key inclusion criteria (3 listed)

Males and females aged ≥40 with COPD, former/current smokers with a ≥10 pack-year smoking history.
Diagnosed with COPD by FEV1/FVC < 0.7 using standard PFT post-bronchodilator testing, with either 'mild' ('GOLD 1': FEV1 ≥ 80% of predicted value) COPD or 'very severe' ('GOLD 4': FEV1 < 30% of predicted value) COPD.
Ability to provide informed consent.

Key exclusion criteria (7 listed)

No existing COPD diagnosis
History of co-morbid asthma
Current use of home oxygen
Any acute exacerbation of COPD (AECOPD) experienced within 4 weeks of participation in the study
Chronic respiratory infection

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
Rapid Expiratory Occlusion Monitor (REOM)Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.	Device	COPD sub-group: GOLD 1 COPD, COPD sub-group: GOLD 4 COPD
Standard oscillometrytremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada	Diagnostic test	COPD sub-group: GOLD 1 COPD, COPD sub-group: GOLD 4 COPD
Standard pulmonary function testStandard-of-care respiratory test.	Diagnostic test	COPD sub-group: GOLD 1 COPD, COPD sub-group: GOLD 4 COPD

Primary outcome

Concordance (correlation)
Time frame: Single-visit study: all tests performed at one single visit.
Correlation will be tested using the Spearman correlation coefficient (r) between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.
Agreement
Time frame: Single-visit study: all tests performed at one single visit.
Agreement will be tested using the Bland-Altman test between REOM-obtained (Reo1 and Reo2) and tremoflo-obtained (R19 and R5) resistance measurements.

2 secondary outcomes

Discriminative capacity
Time frame: Single-visit study: all tests performed at one single visit.
Participant satisfaction and usability experience
Time frame: Single-visit study: all tests performed at one single visit.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
Individual participant dataSharing planned: No

Related trials for Copd

RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 26 Sep 2024. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Concordance (correlation) (time frame: Single-visit study: all tests performed at one single visit.). The study lists 2 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 NCT05913323.

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 Sep 2024.