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

Last updated: September 24, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Rapid Expiratory Occlusion Monitor (REOM)

Standard oscillometry

Standard pulmonary function test

Clinical Study ID

NCT05913323
2023-9001
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females aged ≥40 with COPD, former/current smokers with a ≥10 pack-yearsmoking history.

  • Diagnosed with COPD by FEV1/FVC < 0.7 using standard PFT post-bronchodilatortesting, with either 'mild' ('GOLD 1': FEV1 ≥ 80% of predicted value) COPD or 'verysevere' ('GOLD 4': FEV1 < 30% of predicted value) COPD.

  • Ability to provide informed consent.

Exclusion

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 participationin the study

  • Chronic respiratory infection

  • Any contraindication to respiratory testing

  • Inability to participate in reproducible measurements due to physical or cognitivebarrier

Study Design

Total Participants: 17
Treatment Group(s): 3
Primary Treatment: Rapid Expiratory Occlusion Monitor (REOM)
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
August 06, 2024

Study 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.

Connect with a study center

  • McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

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