Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access

doi:doi:10.1038/sj.jp.7210944

Journal of Perinatology (2003) 23, 378–383. doi:10.1038/sj.jp.7210944

Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access

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.

Dale Gerstmann MD^1,4, Ryan Berg RRT¹, Ron Haskell RRT¹, Cathy Brower RRT¹, Kari Wood MSN¹, Brad Yoder MD², Loren Greenway PhD³, Gordon Lassen RRT¹, Robert Ogden RRT¹, Ronald Stoddard MD¹ and Stephen Minton MD¹

¹Neonatology Department, Utah Valley Regional Medical Center, Provo, UT, USA
²Santa Rosa Children's Hospital, San Antonio, TX, US
³ALDS Hospital, Salt Lake City, UT, USA

Correspondence: Dale R. Gerstmann, MD, Neonatology Department, Utah Valley Regional Medical Center, 1040 North 500 West, Provo, UT 84604, USA.

⁴Dale R. Gerstmann can also be contacted at: Pediatrix Medical Group, Office of Research and Education, 1301 Concord Terrace, Sunrise, FL 33323-2825, USA.

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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.