, Volume 15, Issue 7-8, pp 421-427

Validation of the Natus CO-Stat™ End Tidal BreathAnalyzer in Children and Adults

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Abstract

Objective.The performance of a point-of-care, noninvasive end tidalbreath carbon monoxide analyzer (CO-Stat End Tidal BreathAnalyzer, Natus Medical Inc.) that also reports end tidal carbon dioxide(ETCO2) and respiratory rate (RR), was compared to established,marketed (predicate) devices in children (n = 39) and adults(n = 48) who are normal or at-risk of elevated CO excretion.Methods.Concentrations of end tidal breath CO (ETCO), room air CO,ETCO corrected for inhaled CO (ETCOc), ETCO2, and RR were measuredwith the CO-Stat analyzer and the data compared to thoseobtained from the same subjects using the Vitalograph BreathCO monitor(Vitalograph, Inc.) for ETCOc and the Pryon CO2 monitor (SC210 andSC300, Pryon Corp) for ETCO2 and RR. Adults and children werestudied at three medical centers. The data were analyzed by paired t-tests andlinear regression. Bias and imprecision between the CO-Stat analyzer and thepredicate devices was calculated by the method of Bland and Altman.Results.Paired t-tests, performed on the three parametersmeasured with the CO-Stat analyzer and predicate devices showed that only theETCOc values in the adults and the ETCO2 values in the childrenwere significantly different (lower, p ≤ 0.0001, and higher, p≤ 0.0001, respectively). The mean bias and imprecision of the CO-Statanalyzer for adult ETCOc and children ETCO2measurements were−0.9 ± 1.2 ppm and 0.4 ± 0.6%, respectively. Linearregression analysis for the ETCOc results in children and adults had a highdegree of correlation (r= 0.91 and 0.98, respectively).Conclusions.We conclude that in a clinical environment the NatusCO-Stat End Tidal Breath Analyzer performs at least as wellas predicate devices for the measurements of ETCOc, ETCO2, and RR.