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Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access

Journal of Perinatology volume 23, pages 378–383 (2003)Cite this article

Abstract

OBJECTIVE: To investigate pulse oximetry in neonates who require arterial access as represented by the clinical data recorded to manage their care.

STUDY DESIGN: Analysis of simultaneous SpO2 and SaO2 from: 7-year historical NICU data (N=31,905); 4-month prospective NICU data (N=566); verification data using two hemoximeters (N=52); and NICU data from two collaborating centers (N=95 and 168). The bias function (SpO2−SaO2) was regressed against the measured “gold” standard, SaO2.

RESULTS: A significant negative correlation was found for each of the data sets between the bias function and SaO2. This bias was similar for devices from several manufacturers (Datex-Ohmeda, Masimo, Nellcor, and Spacelabs). Maximum operational performance occurred with peaks between 92 and 97% SaO2, but declined markedly above and below this narrow range. In all, 71 to 95% of patients exhibited data with significant bias.

CONCLUSION: These operational data suggest that with the methodology and devices currently in use, SpO2 values in most all neonates who require arterial lines inaccurately correlate with measured arterial saturation.

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Author notes

  1. Dale Gerstmann: Dale R. Gerstmann can also be contacted at: Pediatrix Medical Group, Office of Research and Education, 1301 Concord Terrace, Sunrise, FL 33323-2825, USA.

Authors and Affiliations

  1. Neonatology Department, Utah Valley Regional Medical Center, Provo, UT, USA

    Dale Gerstmann MD, Ryan Berg RRT, Ron Haskell RRT, Cathy Brower RRT, Kari Wood MSN, Gordon Lassen RRT, Robert Ogden RRT, Ronald Stoddard MD & Stephen Minton MD

  2. Santa Rosa Children's Hospital, San Antonio, TX, US

    Brad Yoder MD

  3. ALDS Hospital, Salt Lake City, UT, USA

    Loren Greenway PhD

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  1. Dale Gerstmann MD
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Additional information

These data were presented in part as a Late Breaker Abstract at the Pediatric Academic Societies mdash; Society for Pediatric Research Meeting, May 2002, Baltimore, MD, USA. An FDA Medical Device Report (#1024269) was filed with Med Watch on March 5, 2002.

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Gerstmann, D., Berg, R., Haskell, R. et al. Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access. J Perinatol 23, 378–383 (2003). https://doi.org/10.1038/sj.jp.7210944

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