title: Validation of the Natus CO-Stat End Tidal Breath Analyzer in children and adults.
abstract: OBJECTIVE
  The performance of a point-of-care, noninvasive end tidal breath carbon monoxide analyzer (CO-Stat End Tidal Breath Analyzer, 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 measured with the CO-Stat analyzer and the data compared to those obtained from the same subjects using the Vitalograph BreathCO monitor (Vitalograph, Inc.) for ETCOc and the Pryon CO2 monitor (SC210 and SC300, Pryon Corp) for ETCO2 and RR. Adults and children were studied at three medical centers. The data were analyzed by paired t-tests and linear regression. Bias and imprecision between the CO-Stat analyzer and the predicate devices was calculated by the method of Bland and Altman.
  
  
  RESULTS
  Paired t-tests, performed on the three parameters measured with the CO-Stat analyzer and predicate devices showed that only the ETCOc values in the adults and the ETCO2 values in the children were significantly different (lower, p < or = 0.0001, and higher, p < or = 0.0001, respectively). The mean bias and imprecision of the CO-Stat analyzer for adult ETCOc and children ETCO2 measurements were -0.9 +/- 1.2 ppm and 0.4 +/- 0.6%, respectively. Linear regression analysis for the ETCOc results in children and adults had a high degree of correlation (r = 0.91 and 0.98, respectively).
  
  
  CONCLUSIONS
  We conclude that in a clinical environment the Natus CO-Stat End Tidal Breath Analyzer performs at least as well as predicate devices for the measurements of ETCOc, ETCO2, and RR.
authors.affiliation: Departments of Pediatric, Stanford University School of Medicine, Stanford, CA 94305-5208, USA. henk.vreman@stanford.edu
authors.forename: H J
authors.initials: HJ
authors.lastname: Vreman
authors.forename: R J
authors.initials: RJ
authors.lastname: Wong
authors.forename: P
authors.initials: P
authors.lastname: Harmatz
authors.forename: A A
authors.initials: AA
authors.lastname: Fanaroff
authors.forename: B
authors.initials: B
authors.lastname: Berman
authors.forename: D K
authors.initials: DK
authors.lastname: Stevenson
mesh_terms: D000293:Adolescent; D000328:Adult; D002245:Carbon Dioxide / Q000032:analysis*; D002248:Carbon Monoxide / Q000032:analysis*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation; D019095:Point-of-Care Systems; D012119:Respiration; D012680:Sensitivity and Specificity; D013990:Tidal Volume
chemical_list: D002245:Carbon Dioxide; D002248:Carbon Monoxide