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Performance Evaluation of New-Generation Pulse Oximeters in the NICU: Observational Study

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Abstract

This crossover observational study compares the data characteristics and performance of new-generation Nellcor OXIMAX and Masimo SET SmartPod pulse oximeter technologies. The study was conducted independent of either original equipment manufacturer (OEM) across eleven preterm infants in a Neonatal Intensive Care Unit (NICU). The SmartPods were integrated with Dräger Infinity Delta monitors. The Delta monitor measured the heart rate (HR) using an independent electrocardiogram sensor, and the two SmartPods collected arterial oxygen saturation (SpO2) and pulse rate (PR). All patient data were non-Gaussian. Nellcor PR showed a higher correlation with the HR as compared to Masimo PR. The statistically significant difference found in their median values (1% for SpO2, 1 bpm for PR) was deemed clinically insignificant. SpO2 alarms generated by both SmartPods were observed and categorized for performance evaluation. Results for sensitivity, positive predictive value, accuracy and false alarm rates were Nellcor (80.3, 50, 44.5, 50%) and Masimo (72.2, 48.2, 40.6, 51.8%) respectively. These metrics were not statistically significantly different between the two pulse oximeters. Despite claims by OEMs, both pulse oximeters exhibited high false alarm rates, with no statistically or clinically significant difference in performance. These findings have a direct impact on alarm fatigue in the NICU. Performance evaluation studies can also impact medical device purchase decisions made by hospital administrators.

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Acknowledgments

The authors would like to acknowledge Will Greenwood and Amna Basharat for computing, and Romaissa Saadi for data entry support.

Ethical Standard

All procedures performed in the study involving human subjects were in accordance with the ethical standards of the CHEO REB and approved by it. This study does not involve any animal subjects. This research received no specific Grant from any funding agency in the public, commercial or not-for-profit sectors.

Conflict of interest

None of the authors have any conflict of interest to declare as per the ICMJE form for disclosure of potential conflict of interest.

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Authors and Affiliations

  1. Systems and Computer Engineering, Carleton University, 1125 Colonel By Drive, Ottawa, ON, K1S 5B6, Canada

    Shermeen Nizami

  2. Clinical Engineering, The Children’s Hospital of Eastern Ontario, Ottawa, Canada

    Shermeen Nizami & Kim Greenwood

  3. Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada

    Nick Barrowman & JoAnn Harrold

  4. Division of Neonatology, The Children’s Hospital of Eastern Ontario, Ottawa, Canada

    JoAnn Harrold

Authors
  1. Shermeen Nizami
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  2. Kim Greenwood
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  4. JoAnn Harrold
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Corresponding author

Correspondence to Shermeen Nizami.

Additional information

Associate Editor Ajit P. Yoganathan oversaw the review of this article.

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Nizami, S., Greenwood, K., Barrowman, N. et al. Performance Evaluation of New-Generation Pulse Oximeters in the NICU: Observational Study. Cardiovasc Eng Tech 6, 383–391 (2015). https://doi.org/10.1007/s13239-015-0229-7

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  • DOI: https://doi.org/10.1007/s13239-015-0229-7

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