Non-inferiority of Portable Versus Desktop Spirometry

National Institute for Tuberculosis and Lung Diseases, Poland

Status: Completed

Conditions: Asthma; COPD

Treatments: Device: Spirometer USB CPFS/D (MGC Diagnostics); Device: AioCare

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03894475

KB-6

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age>18.
2. Diagnosed asthma or COPD
3. Signed consent to participation in the research experiment.
4. Ability to comply with the spirometry protocol.

Exclusion criteria

1. Pregnant females (based on declaration; no pregnancy tests are planned before the test).
2. Recent myocardial infarction (<30 days).
3. Known thoracic, aortic or cerebral aneurysm.
4. Recent stroke, eye surgery, thoracic/abdominal surgery.
5. Haemoptysis.
6. Recent pneumothorax.
7. Uncontrolled hypertension.
8. Pulmonary Embolism.
9. Angina.
10. Chest or abdominal pain of any etiology.
11. Oral or facial pain exacerbated by a mouthpiece.
12. Stress incontinence.
13. Dementia or state of confusion. 14, Acute Diarrhea

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Sequence A

Active Comparator group

Description:

Patient would first perform an examination with handheld spirometer (AioCare), followed by measurements with the reference spirometer (MGC)

Treatment:

Device: Spirometer USB CPFS/D (MGC Diagnostics)

Device: AioCare

Sequence B

Active Comparator group

Description:

Patient would first perform an examination with the reference spirometer (MGC), followed by measurements with handheld spirometer (AioCare)

Treatment:

Device: Spirometer USB CPFS/D (MGC Diagnostics)

Device: AioCare