Background: Measurement of mixed venous hemoglobin oxygen saturation v
ia catheters employing reflectance spectrophotometry has been availabl
e for more than 10 yr. Despite numerous clinical reports that have pre
sented data showing the poor accuracy of these devices when used clini
cally, they are still widely used in clinical care. The reason for lac
k of agreement with measurements made using bench spectrophotometry is
unclear. The purpose of this study is to define the performance limit
ations of three hemoglobin oxygen saturation catheters (Oximetrix 3, S
AT-2, and HEMOPRO(2)) in a controlled laboratory environment using a b
lood now loop primed with fresh whole human blood as a model. Our hypo
thesis is that the performance limitations of these devices represent
inherent limitations in the technology, not error introduced by patien
t anatomy and physiology. Methods: Blood was equilibrated in a flow lo
op to four analytic gas mixtures designed to achieve oxygen saturation
of approximately 50%, 60%, 70%, and 80%, respectively, with carbon di
oxide tension, pH, and temperature held constant. Saturation readings
from the catheters were collected on-line by microcomputer. Periodic b
lood samples were withdrawn from the flow loop for analysis on a bench
spectrophotometer and subsequent comparison with catheter-derived val
ues.Results: By all measures, performances of the Oximetrix 3 and SAT-
2 systems were comparable (all data are presented as percent saturatio
n unless otherwise noted); bias +/- precision was 3.20 +/- 2.47 and -1
.25 +/- 3.36, respectively, versus -9.97 +/- 7.05 for the HEMOPRO(2).
The 95% confidence limits based on intracatheter variability were +/-
3.49, +/- 2.90, and +/- 9.13 for the Oximetrix 3, SAT-2, and HEMOPRO(2
), respectively. The 95% confidence limits based on total variability,
although similar for Oximetrix 3 (+/- 4.83) and SAT-2 (+/- 6.59), wer
e larger for the HEMOPRO(2) (+/- 13.82). The 95% confidence intervals
for agreement between catheter brands were -2.14, 11.04 (Oximetrix 3 -
SAT-2); -0.18, 26.52 (Oximetrix 3 - HEMOPRO(2)) and -5.24, 22.68 (SAT
-2 - HEMOPRO(2)). Conclusions: While the Oximetrix 3 and SAT-2 may be
acceptable as continuous monitors used to detect changes or trends, no
ne of the three systems is equivalent to conventional bench oximetry f
or the measurement of hemoglobin oxygen saturation.