Key result
The Terumo CDI 500 and Spectrum Medical Quantum devices reported hemoglobin within 1 g/dL of the ABL90 analyzer 86.9% and 87.5% of the time, but limits of agreement were too large for substitution.
Why the study?
To examine and compare the accuracy of the Terumo CDI 500 and the Spectrum Medical Quantum against each other and an ABL90 FLEX benchtop blood analyzer.
Do the Terumo CDI 500 and Spectrum Medical Quantum devices accurately measure hemoglobin and oxygen saturation compared to a benchtop blood analyzer in patients undergoing cardiopulmonary bypass?
Observational (n=519)
No
Do the Terumo CDI 500 and Spectrum Medical Quantum devices accurately measure hemoglobin and oxygen saturation compared to a benchtop blood analyzer in patients undergoing cardiopulmonary bypass?
p-value: p=<0.001
The Terumo CDI 500 and Spectrum Medical Quantum devices show statistically significant differences compared to benchtop analyzers and should only be used as trending devices during cardiopulmonary bypass.
Device hemoglobin values should not replace benchtop analysis during CPB; Level 3 data leaves open their utility as trending monitors.
To examine the accuracy between analyzers, the Terumo CDI 500 and the Spectrum Medical Quantum were compared to each other and to the ABL90 FLEX benchtop blood analyzer. Patients were retrospectively identified who underwent cardiac surgery requiring cardiopulmonary bypass between August 1, 2018 and November 1, 2019. Hemoglobin and venous saturation (SvO2) values from all three analyzers were collected. Measurements from the Quantum and the CDI 500 were averaged over 1 minute to provide a single value for the minute for the given device. Blood analysis on the ABL90 benchtop device was performed at a minimum of every hour during congenital cardiopulmonary bypass (CPB). There were 519 patients included in the analysis. Data points numbering 69,404 and 70,598 were analyzed when comparing the CDI 500 to the Quantum for hemoglobin and SvO2, respectively. Comparison of hemoglobin and SvO2for the CDI 500 and Quantum versus ABL90 used 2283 and 1414 data points respectively, in each group. The CDI 500 and Quantum reported hemoglobin within 1 g/dL of the ABL90 86.9% and 87.5% of the time, respectively. The CDI 500 and Quantum reported SvO2within 3% of the ABL90 61.0% and 57.9% of the time, respectively. The mean difference between the CDI 500 and Quantum hemoglobin and SvO2measurements equaled .194 g/dL (p < .001) and .861% (p < .001), respectively and were both significantly different from zero. All device comparisons were statistically significantly different when compared to zero difference, likely due to the large data set as the magnitudes of these differences are all quite small and may not be clinically significant. However, while the reader should judge for themselves based upon their specific practice, in our opinion, the 95% Limit of Agreement was too large for either the CDI 500 or Quantum hemoglobin and SvO2values to be substituted for ABL90 values. As recommended by the manufacturers, the CDI 500 and Quantum should only be used as a trending device.
No takes yet. Share an insight, caveat, or question.
Reagor et al. (2021) conducted an observational in Cardiac surgery requiring cardiopulmonary bypass (n=519). Terumo CDI 500 and Spectrum Medical Quantum vs. ABL90 FLEX benchtop blood analyzer was evaluated on Accuracy of hemoglobin and venous oxygen saturation (SvO2) measurements compared to the ABL90 benchtop analyzer (p=<0.001). The Terumo CDI 500 and Spectrum Medical Quantum devices reported hemoglobin within 1 g/dL of the ABL90 analyzer 86.9% and 87.5% of the time, but limits of agreement were too large for substitution.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: