Comparability of portable and desktop spirometry: a randomized, parallel assignment, open-label clinical trial

Area of Science:

• Pulmonary Medicine
• Medical Device Technology
• Respiratory Diagnostics

Background:

• Portable spirometers are often perceived as inaccurate for clinical use.
• Evaluating new portable devices is crucial for improving remote respiratory care.
• The AioCare® is a novel portable spirometer requiring performance validation.

Purpose of the Study:

• To assess the diagnostic accuracy and performance of the AioCare® portable spirometer.
• To compare AioCare® spirometry readings against a reference desktop spirometer.
• To determine the reliability of AioCare® for patients with chronic lung diseases.

Main Methods:

• Sixty-two patients with asthma or COPD underwent spirometry using both AioCare® and a reference device.
• Patients were randomized to determine the order of spirometer use.
• Key parameters including FEV₁, FVC, PEF, and FEV₁/FVC ratio were measured and compared.

Main Results:

• High correlations were observed for FEV₁, FVC, PEF, and FEV₁/FVC between the AioCare® and reference spirometers.
• Mean differences were minimal and statistically non-significant for all measured parameters (p > 0.05).
• Pearson correlation coefficients demonstrated strong associations (R > 0.95) for all parameters.

Conclusions:

• The AioCare® portable spirometer demonstrates comparable performance to a reference desktop spirometer.
• This device shows potential as a reliable tool for the remote management of patients with lung diseases.
• Findings support the use of AioCare® as a complementary diagnostic tool in respiratory care settings.