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

McGill University

Status: Completed

Conditions: Copd

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05913323

2023-9001

Details and patient eligibility

About

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.

Full 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:

1. To investigate the discriminative capacity of the parameters obtained from the REOM to distinguish between 'mild' and 'very severe' COPD.
2. To collect descriptive information on the participant user experience with the REOM.
3. 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.

Enrollment: 17 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

17 participants in 2 patient groups

COPD sub-group: GOLD 1 COPD

Description:

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.

Treatment:

Diagnostic Test: Standard oscillometry

Diagnostic Test: Standard pulmonary function test

Device: Rapid Expiratory Occlusion Monitor (REOM)

COPD sub-group: GOLD 4 COPD

Description:

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.

Treatment:

Diagnostic Test: Standard oscillometry

Diagnostic Test: Standard pulmonary function test

Device: Rapid Expiratory Occlusion Monitor (REOM)