Non-inferiority of Portable Versus Desktop Spirometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer
研究概览
简要总结
The investigators compared the ventilation parameters for volume and flow obtained from standard spirometry procedures from patients presently monitored and treated for asthma or chronic obstructive pulmonary disease (COPD) using AioCare (HealthUp Sp. z o.o., Serial Number: MS082017005412, software version: MySpiroo app 1.1.14) as the tested device and Spirometer USB CPFS/D (MGC Diagnostics) as the reference, which required calibration prior to each session. Spirometry measurements were performed on sixty-two patients (forty-four females (58±17 years old) and eighteen males (52±19 years old)) at the Institute of Tuberculosis and Lung Disease in Warsaw, Poland. Participants were asked to perform correct spirometry examinations (which means at least three technically correct exhales and meeting repeatability criteria for FEV1 and FVC) on both measuring devices with a five-minute break between devices to prevent respiratory muscle fatigue. The highest value from all acceptable spirometry results was then used for analysis. All spirometry examinations followed ERS/ATS standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed asthma or COPD
- •Signed consent to participation in the research experiment.
- •Ability to comply with the spirometry protocol.
排除标准
- •Pregnant females (based on declaration; no pregnancy tests are planned before the test).
- •Recent myocardial infarction (<30 days).
- •Known thoracic, aortic or cerebral aneurysm.
- •Recent stroke, eye surgery, thoracic/abdominal surgery.
- •Haemoptysis.
- •Recent pneumothorax.
- •Uncontrolled hypertension.
- •Pulmonary Embolism.
- •Chest or abdominal pain of any etiology.
- •Oral or facial pain exacerbated by a mouthpiece.
- •Stress incontinence.
- •Dementia or state of confusion. 14, Acute Diarrhea
结局指标
主要结局
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer
时间窗: 6 months
Comparison of Peak Expiratory Flow obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer
时间窗: 6 months
Comparison of Forced Expiratory Volume in the first second (FEV1) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer
时间窗: 6 months
Comparison of Forced Vital Capacity (FVC) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)
次要结局
未报告次要终点
研究者
Piotr Boros
Prof. Piotr Boros, M.D., Ph.D.
National Institute for Tuberculosis and Lung Diseases, Poland