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OpenTrials
Completed

NCT Number: NCT03894475

Non-inferiority of Portable Versus Desktop Spirometry

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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Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute for Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, 01-138, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Angina.
  • 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

Treatment and study plan

AioCare

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)

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.

Primary outcomes

  1. Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer

    Time frame: 6 months

    Comparison of Peak Expiratory Flow obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)

  2. Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer

    Time frame: 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)

  3. Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer

    Time frame: 6 months

    Comparison of Forced Vital Capacity (FVC) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)

Sponsors and collaborators

Lead sponsor

National Institute for Tuberculosis and Lung Diseases, Poland

Other

Collaborators

  • Healthup Sp. z o.o.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 28, 2019
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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