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Validation of the Masimo O3™ regional oximetry device in pediatric patients undergoing cardiac surgery

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Abstract

We assessed the accuracy of Masimo O3™ regional cerebral oxygen saturation (rSO2) readings by comparing them with reference values and evaluated the relationship between rSO2 and somatic tissue oxygen saturation (StO2) in children undergoing cardiac surgery. After anesthesia induction, pediatric sensors were applied to the forehead and foot sole, and rSO2 and StO2 values were monitored continuously. Before cardiopulmonary bypass (CPB), FIO2 was set to 0.2, 0.5, and 0.8 serially every 15 min. After CPB, FIO2 was reversed. The reference values (SavO2) were calculated by combining arterial (SaO2) and central venous oxygen saturation (SvO2) readings from the arterial and central lines, respectively (0.7 \(\times\) SvO2 + 0.3 \(\times\) SaO2). In total, 265 pairs of rSO2/StO2 and SavO2 from 49 patients were analyzed. The bias, standard deviation (SD), standard error (SE), and root mean squared error (RMSE) of rSO2 were 2.6%, 4.5%, 0.3%, and 4.3%, respectively. The limits of agreement ranged from -6.3% to 11.6%. Trend accuracy analysis yielded a relative mean error of -1.4%, with an SD of 4.3%, SE of 0.2%, and RMSE of 3.9%. According to multiple linear regression analysis, the application of CPB, FIO2, Hb level, and tip location of the central venous catheter influenced the bias (all P < 0.05). Furthermore, the correlation between rSO2 and StO2 was weak (r = 0.254). rSO2 readings by the Masimo O3™ device and pediatric sensor had good absolute and trending accuracies with respect to the calculated reference values in children undergoing cardiac surgery. rSO2 and StO2 cannot be used interchangeably.

Clinical trial registration http://clinicaltrials.gov (number: NCT04208906).

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Data availability

The datasets generated during the current study are available from the corresponding author on reasonable request.

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Author notes

  1. Ji-Hyun Lee and In-Sun Song have contributed equally to the work.

Authors and Affiliations

  1. Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, # 101 Daehakno, Jongnogu, Seoul, 03080, Republic of Korea

    Ji-Hyun Lee, In-Sun Song, Pyoyoon Kang, Sang-Hwan Ji, Young-Eun Jang, Eun-Hee Kim, Hee-Soo Kim & Jin-Tae Kim

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  1. Ji-Hyun Lee
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  2. In-Sun Song
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  3. Pyoyoon Kang
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  4. Sang-Hwan Ji
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  5. Young-Eun Jang
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  6. Eun-Hee Kim
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  7. Hee-Soo Kim
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  8. Jin-Tae Kim
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Contributions

J-HL: This author helped in the study design, patient recruitment, data collection, data analysis, and writing of the manuscript. ISS: This author helped in the patient recruitment, data analysis, and data collection, and writing of the manuscript. PK: This author helped in the study design, patient recruitment, and data collection. S-HJ: This author helped in the patient recruitment, data analysis, and data collection. Y-EJ: This author helped in the study design, and data collection. E-HK: This author helped in the patient recruitment, data analysis, and data collection. H-SK: This author helped in the study design, data collection and data analysis. J-TK: This author helped in the study design, patient recruitment, data collection, data analysis, and writing of the manuscript.

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Correspondence to Jin-Tae Kim.

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The study protocol was approved by the Institutional Review Board of Seoul National University Hospital (H1911-099-1081; date of approval: 3rd January, 2020).

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Lee, JH., Song, IS., Kang, P. et al. Validation of the Masimo O3™ regional oximetry device in pediatric patients undergoing cardiac surgery. J Clin Monit Comput 36, 1703–1709 (2022). https://doi.org/10.1007/s10877-022-00815-3

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  • DOI: https://doi.org/10.1007/s10877-022-00815-3

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