Assessment of Respiratory Rate and Simulated Apnea Utilizing the PneumoWave Biosensor: In Vitro and In Vivo Validation.

Accurate monitoring of respiratory rates is critical for early detection of a range of clinical conditions. However, standard manual counting or inadequate clinical monitoring often fails to provide reliable measurements. This study evaluated and validated the PneumoWave biosensor for respiratory rate measurement across a broad physiological range and different body postures (45°, 90°, and 180°) in both in vitro and in vivo settings. In vitro validation was performed using a SimMan ALS manikin operated at respiratory settings of 6-30 breaths per minute, with 10 s periods of simulated apnea. In vivo validation involved 20 healthy volunteers performing metronome-guided breathing while wearing bilateral PneumoWave biosensors. In vitro results demonstrated an excellent correlation between biosensors and manikin respiratory settings and captured all apnea events (r = 0.99, ICC = 0.99). In vivo findings showed good agreement with direct observational count (r = 0.99, R2 = 0.99, ICC = 0.99), with 97% of apnea events captured by both devices in all positions. Body postures had no significant impact on biosensor accuracy. These findings demonstrate that the PneumoWave biosensor provides accurate and reliable respiratory monitoring and supports its potential as a robust, non-invasive tool for continuous clinical and remote patient monitoring.