Accuracy of Wireless Pulse Oximeter on Preterm or <2.5 kg Infants

Abstract

Objective Monitoring heart rate (HR) and oxygen saturation (SpO₂) in infants is essential in the neonatal intensive care unit. Wireless pulse oximeter technology has been advancing but with limited accuracy data on preterm infants. This observational study compared HR and SpO₂ of the wireless Owlet Smart Sock 3 (OSS3) to the wired Masimo SET (Masimo) pulse oximeter in preterm or <2.5 kg infants.

Study Design Twenty-eight eligible infants were enrolled. They weighed between 1.7 and 2.5 kg and were without anomalies or medical instability. OSS3 and Masimo simultaneously monitored HR and SpO₂ for 60 minutes. The data were aligned by time epoch and filtered for poor tracings. The agreement was compared using the Pearson's correlation coefficient, the Bland–Altman method, average root mean square (ARMS), and prevalence and bias adjusted kappa (PABAK) analyses.

Results Two infants' data were excluded due to motion artifacts or device failures. The corrected gestational age and current weights were 35 ± 3 weeks and 2.0 ± 0.2 kg (mean ± standard deviation), respectively. Over 21 hours of data showed that HR was strongly correlated between the two devices (r = 0.98, p < 0.001), with a difference of −1.3 beats per minute (bpm) and the limit of agreement (LOA) −6.3 to 3.4 bpm based on the Bland–Altman method. SpO₂ was positively correlated between the two devices (r = 0.71, p < 0.001) with a SpO₂ bias of 0.3% (LOA: −4.6 to 4.5%). The estimated ARMS of OSS3 compared with Masimo was 2.3% for SpO₂ in the 70 to 100% range. The precision decreased with lower SpO₂. A strong agreement (PABAK = 0.94) was between the two devices on whether SpO₂ was above or below 90%.

Conclusion OSS3 provided comparable HR and SpO₂ accuracy to Masimo in preterm or <2.5 kg infants. Motion artifacts, lack of arterial blood gas comparisons, and lack of racial and ethnic diversity are the study limitations. More OSS3 data on the Lower HR and SpO₂ ranges were needed before implementing inpatient use.

Key Points

• Pulse oximeters are vital for monitoring preterm infants' HR and SpO₂ levels.

• Limited data exist on the accuracy of the wireless OSS3 on preterm infants.

• This observational study found that the OSS3 is comparable to the Masimo SET in measuring HR and SpO₂ in preterm or <2.5 kg infants.

Keywords

wearable - wireless - wired - pulse oximeter - preterm infants - heart rate - oxygen saturation

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