Non-inferiority of Portable Versus Desktop Spirometry

Asthma Clinical Trial

Official title:

Non-inferiority of Portable Versus Desktop Spirometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894475
• Other study ID #: KB-6
• Status: Completed
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: March 2019
• Source: National Institute for Tuberculosis and Lung Diseases, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 21, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

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).
• 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.

Locations

Country	Name	City	State
Poland	National Institute for Tuberculosis and Lung Diseases	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
National Institute for Tuberculosis and Lung Diseases, Poland	HealthUp Sp. z o.o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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