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

Authors' Contributions

M.T., H.D., and B.C. contributed to the conception and design of the study, data collection, data analysis, and manuscript preparation; B.P. and T.M. contributed to the parental consent process and data collection; C.J. contributed to the data processing; Y.S. contributed to the manuscript preparation and review. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

^# Heather Day and Micaela Thomas are co-first authors.

Publikationsverlauf

Eingereicht: 02. September 2022

Angenommen: 06. März 2023

Artikel online veröffentlicht:
18. April 2023

• References

• 1 Martin RJ, Di Fiore JM, Macfarlane PM, Wilson CG. Physiologic basis for intermittent hypoxic episodes in preterm infants. Adv Exp Med Biol 2012; 758: 351-358
• 2 Memon SF, Memon M, Bhatti S. Wearable technology for infant health monitoring: a survey. IET Circuits Dev Syst 2020; 14 (02) 115-129
• 3 Harrell MD, Dobson NR, Olsen C, Ahmed A, Hunt CE. Inpatient comparison of wireless and wired pulse oximetry in neonates. J Neonatal Perinatal Med 2022; 15 (02) 283-289
• 4 Owlet Dream Sock. . Accessed August 26, 2022 at: https://owletcare.com/products/owlet-smart-sock
• 5 Bonafide CP, Localio AR, Ferro DF. et al. Accuracy of pulse oximetry-based home baby monitors. JAMA 2018; 320 (07) 717-719
• 6 Pulse oximeters – premarket notification submissions [510k] guidance for industry and Food and Drug Administration staff. Accessed August 26, 2022 at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-drug
• 7 Masimo advanced alarm performance: an evidence-based approach to reduce false alarms and nuisance alarms. Accessed November 9, 2022 at: https://www.masimo.tw/pdf/whitepaper/LAB6138B.pdf
• 8 Hay Jr WW, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol 2002; 22 (05) 360-366
• 9 Shah N, Ragaswamy HB, Govindugari K, Estanol L. Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers. J Clin Anesth 2012; 24 (05) 385-391
• 10 Keerthy S, Nagesh NK. Efficacious continuous monitoring of infants using wireless remote monitoring technology. Indian J Pediatr 2022; 89 (08) 771-775
• 11 Henry C, Shipley L, Ward C. et al. Accurate neonatal heart rate monitoring using a new wireless, cap mounted device. Acta Paediatr 2021; 110 (01) 72-78
• 12 Rimet Y, Brusquet Y, Ronayette D. , et al. Evaluation of a new, wireless pulse oximetry monitoring system in infants: the BBA bootee. (eds) 4th International Workshop on Wearable and Implantable Body Sensor Networks (BSN 2007). IFMBE Proceedings, Springer, Berlin, Heidelberg. 2007;13:143–148.
• 13 da Costa JC, Faustino P, Lima R, Ladeira I, Guimarães M. Research: comparison of the accuracy of a pocket versus standard pulse oximeter. Biomed Instrum Technol 2016; 50 (03) 190-193
• 14 Joshi R, Kommers D, Oosterwijk L, Feijs L, van Pul C, Andriessen P. Predicting neonatal sepsis using features of heart rate variability, respiratory characteristics, and ECG-derived estimates of infant motion. IEEE J Biomed Health Inform 2020; 24 (03) 681-692
• 15 Anjewierden S, Humpherys J, LaPage MJ, Asaki SY, Aziz PF. Detection of tachyarrhythmias in a large cohort of infants using direct-to-consumer heart rate monitoring. J Pediatr 2021; 232: 147-153.e1
• 16 Singh AK, Sahi MS, Mahawar B, Rajpurohit S. Comparative evaluation of accuracy of pulse oximeters and factors affecting their performance in a tertiary intensive care unit. J Clin Diagn Res 2017; 11 (06) OC05-OC08
• 17 Wackernagel D, Blennow M, Hellström A. Accuracy of pulse oximetry in preterm and term infants is insufficient to determine arterial oxygen saturation and tension. Acta Paediatr 2020; 109 (11) 2251-2257
• 18 Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial bias in pulse oximetry measurement. N Engl J Med 2020; 383 (25) 2477-2478
• 19 Griksaitis MJ, Scrimgeour GE, Pappachan JV, Baldock AJ. Accuracy of the Masimo SET® LNCS neo peripheral pulse oximeter in cyanotic congenital heart disease. Cardiol Young 2016; 26 (06) 1183-1186
• 20 Utah: 2020 census. Accessed August 26, 2022 at: https://www.census.gov/library/stories/state-by-state/utah-population-change-between-census-decade.html.