Motion resistance in peripheral oxygen saturation monitoring using Biolight Analog SpO2 compared to Masimo SpO2: a non-inferiority study.

Background: Pulse oximeters are vital for assessing blood oxygen levels but can produce inaccurate readings during patient motion, leading to false alarms and alarm fatigue. Analog SpO₂ Technology, which uses analog waveforms to filter motion artifacts, may improve accuracy compared to digital sensors. However, the effectiveness of this technology in reducing false alarms in clinical settings remains unclear. This study assesses and compares the motion resistance of Analog SpO₂ Technology of two devices in the market.

Methods: Thirty healthy adults underwent controlled experiments (Control, Linear Motion, Angular Motion) using two pulse oximeters. Linear Motion tested hand displacement impact, while Angular Motion involved rhythmic hand motions at 120 bpm and 160 bpm.

Results: Both devices performed similarly in Control, with no disruptions. In Linear Motion, mild disruptions occurred, but no significant differences in SpO₂ readings or alarms. Angular Motion at 120 bpm showed stability with no alarms. At 160 bpm, Device B (Biolight Analog SpO₂) had fewer technical alarms but more SpO₂ alarms than Device A (Masimo Analog SpO₂).

Conclusions: Analog SpO₂ exhibited motion resistance under static, linear and continuous waving angular motion up to 120 bpm and 160 bpm, but alarms occurred at 160 bpm with continuous tapping angular motion. These findings signify non-inferiority of either device in clinical settings. Further studies should include patients with cardiovascular and/or respiratory diseases.

Trial registration: The study was submitted to and approved by the Biolight Ethics Committee (S0723), and written informed consent from all participants was obtained.