PIKO-6® vs. forced spirometry in asthmatic children.

Area of Science:

• Pediatric Pulmonology
• Respiratory Diagnostics
• Medical Device Evaluation

Background:

• The PIKO-6® is an electronic device measuring forced expiratory volume in 1 (FEV1) and 6 (FEV6) seconds during a forced vital capacity (FVC) maneuver.
• This device holds potential for diagnosing obstructive respiratory diseases.

Purpose of the Study:

• To assess the concordance of FEV1, FEV6, and FEV1/FEV6 measurements obtained with the PIKO-6® device compared to standard spirometry.
• To evaluate these concordances in both asthmatic children and healthy controls.

Main Methods:

• A cross-sectional study involving 82 children aged 6-14 years (58 with asthma, 24 healthy).
• Participants underwent both standard spirometry and PIKO-6® testing to compare pulmonary function measurements.

Main Results:

• Concordance correlation coefficients (CCC) for FEV1 and FEV6 between PIKO-6® and spirometry were high (0.938 and 0.927, respectively).
• However, broad limits of agreement for FEV1 and FEV6 suggest non-interchangeability of results.
• Concordance was notably lower in children with partially controlled or uncontrolled asthma compared to those with controlled asthma or healthy children.

Conclusions:

• The PIKO-6® device demonstrates lower concordance with spirometry in asthmatic children, particularly those with poorly controlled disease.
• The FEV1, FEV6, and FEV1/FEV6 values from PIKO-6® are not interchangeable with spirometry results due to wide limits of agreement.
• Longitudinal studies are recommended to determine the clinical utility of PIKO-6® in asthma patient management.