Non-inferiority of Portable Versus Desktop Spirometry

Not Applicable

Completed

• Conditions: COPD; Asthma
• Interventions: Device: AioCare; Device: Spirometer USB CPFS/D (MGC Diagnostics)

• Registration Number: NCT03894475
• Lead Sponsor: National Institute for Tuberculosis and Lung Diseases, Poland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-18
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Status Verified: 2019-03
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-26
• Last Update Submitted: 2019-03-26
• Study First Posted: 2019-03-28
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence A	AioCare	Patient would first perform an examination with handheld spirometer (AioCare), followed by measurements with the reference spirometer (MGC)
Sequence A	Spirometer USB CPFS/D (MGC Diagnostics)	Patient would first perform an examination with handheld spirometer (AioCare), followed by measurements with the reference spirometer (MGC)
Sequence B	Spirometer USB CPFS/D (MGC Diagnostics)	Patient would first perform an examination with the reference spirometer (MGC), followed by measurements with handheld spirometer (AioCare)
Sequence B	AioCare	Patient would first perform an examination with the reference spirometer (MGC), followed by measurements with handheld spirometer (AioCare)

Primary Outcome Measures

Name	Time	Method
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer	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	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	6 months	Comparison of Forced Vital Capacity (FVC) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)

Trial Locations

Locations (1)

National Institute for Tuberculosis and Lung Diseases; 🇵🇱 Warsaw, Mazowieckie, Poland