Non-inferiority of Portable Versus Desktop Spirometry

NCT03894475 | Completed DMC

• 1 other identifier: KB-6
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD

Keywords

Asthma; COPD; Mobile Spirometry

Outcome Measures

Primary Outcomes (3)

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

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

  6 months

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

  Comparison of Forced Expiratory Volume in the first second (FEV1) obtained during a standard dynamic spirometry measured with AioCare (HealthUp) and reference spirometer (MGC)

  6 months

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

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

  6 months

Study Arms (2)

Sequence A

ACTIVE COMPARATOR

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

Device: AioCare; Device: Spirometer USB CPFS/D (MGC Diagnostics)

Sequence B

ACTIVE COMPARATOR

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

Device: AioCare; Device: Spirometer USB CPFS/D (MGC Diagnostics)

Interventions

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).

Sequence A; Sequence B

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.

Sequence A; Sequence B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute for Tuberculosis and Lung Diseases, Poland: lead
• Healthup Sp. z o.o.: collaborator

Study Sites (1)

National Institute for Tuberculosis and Lung Diseases

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Piotr Boros, Prof. dr hab. n. med.

  National Institute for Tuberculosis and Lung Diseases, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Piotr Boros, M.D., Ph.D.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 28, 2019
• Study Start: December 18, 2017
• Primary Completion: June 21, 2018
• Study Completion: June 21, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

PL (1)