Non-inferiority of Portable Versus Desktop Spirometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-06-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sequence A

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

Group Type ACTIVE_COMPARATOR

AioCare

Intervention Type DEVICE

AioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6).

Spirometer USB CPFS/D (MGC Diagnostics)

Intervention Type DEVICE

Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers.

Sequence B

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

Group Type ACTIVE_COMPARATOR

AioCare

Intervention Type DEVICE

AioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6).

Spirometer USB CPFS/D (MGC Diagnostics)

Intervention Type DEVICE

Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers.

Interventions

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AioCare

AioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6).

Intervention Type DEVICE

Spirometer USB CPFS/D (MGC Diagnostics)

Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No