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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Concordance (correlation)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Concordance (correlation)
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Bryan Ross
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre