MedTrace Logo

Non-inferiority of Portable Versus Desktop Spirometry

NCT03894475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2019-03-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

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).

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.

Sponsors & Collaborators

  • Healthup Sp. z o.o.

    collaborator INDUSTRY

  • National Institute for Tuberculosis and Lung Diseases, Poland

    lead OTHER

Principal Investigators

  • Piotr Boros, Prof. dr hab. n. med. · National Institute for Tuberculosis and Lung Diseases, Poland

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2018-06-21
Completion
2018-06-21

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894475 on ClinicalTrials.gov