Non-inferiority of Portable Versus Desktop Spirometry - Trial NCT03894475
Access comprehensive clinical trial information for NCT03894475 through Pure Global AI's free database. This phase not specified trial is sponsored by National Institute for Tuberculosis and Lung Diseases, Poland and is currently Completed. The study focuses on Asthma,COPD. Target enrollment is 62 participants.
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Study Focus
Sponsor & Location
National Institute for Tuberculosis and Lung Diseases, Poland
Timeline & Enrollment
N/A
Dec 18, 2017
Jun 21, 2018
Primary Outcome
Non-inferiority of PEF between AioCare and CPFS/D USB Spirometer,Non-inferiority of FEV1 between AioCare and CPFS/D USB Spirometer,Non-inferiority of FVC between AioCare and CPFS/D USB Spirometer
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03894475
Device Trial