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

NCT05913323 | Completed

• 1 other identifier: 2023-9001
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 'mild' as well as 'very severe' forms of chronic obstructive pulmonary disease (COPD). This study also intends to study the user experience with this handheld portable device.

Conditions

Copd

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Single-visit study: all tests performed at one single visit.

Secondary Outcomes (2)

• Discriminative capacity

  Single-visit study: all tests performed at one single visit.

• Participant satisfaction and usability experience

  Single-visit study: all tests performed at one single visit.

Study Arms (2)

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.

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.

Device: Rapid Expiratory Occlusion Monitor (REOM); Diagnostic Test: Standard oscillometry; Diagnostic Test: Standard pulmonary function test

Interventions

Rapid Expiratory Occlusion Monitor (REOM) DEVICE

Device for which Health Canada approval (ITA Authorization) has been obtained for use in the present study.

COPD sub-group: GOLD 1 COPD; COPD sub-group: GOLD 4 COPD

Standard oscillometry DIAGNOSTIC_TEST

tremoflo device-100, Thorasys Thoracic Medical Systems Inc., Montreal, Canada

COPD sub-group: GOLD 1 COPD; COPD sub-group: GOLD 4 COPD

Standard pulmonary function test DIAGNOSTIC_TEST

Standard-of-care respiratory test.

COPD sub-group: GOLD 1 COPD; COPD sub-group: GOLD 4 COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• McGill University: collaborator
• Thorasys Thoracic Medical Systems Inc.: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: August 1, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)