Skip to main content
OpenTrials
Completed

NCT Number: NCT05913323

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapid Expiratory Occlusion Monitor (REOM)

Device

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

Standard oscillometry

Diagnostic Test

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

Standard pulmonary function test

Diagnostic Test

Standard-of-care respiratory test.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Discriminative capacity

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

    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.

  2. Participant satisfaction and usability experience

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

    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.

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • McGill University
  • Thorasys Thoracic Medical Systems Inc.

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.