Performance evaluation of a noninvasive hemoglobin monitoring device.
OBJECTIVE
Hemoglobin measurement is a routine procedure, and a noninvasive point-of-care device may increase the quality of care. The aim of the present study is to compare hemoglobin concentration values obtained with a portable totally noninvasive device, the Masimo Labs Radical-7 Pulse CO-Oximeter, with the results obtained by the ADVIA 2120 in the laboratory.


METHODS
This was a prospective monocentric open trial enrolling patients consulting in the emergency department of a university hospital from June 16 to December 17, 2009. The main outcome measure was the agreement between both methods and evaluation of the percentage of potential decision error for transfusion.


RESULTS
Samples from 300 consecutive patients were assessed. Hemoglobin concentration could not be obtained with the new device for 24 patients. In others, the mean bias, the lower and the upper limits of agreement between the 2 methods, was 1.8 g/dL (95% estimated confidence interval [CI] 1.5 to 2.1 g/dL), -3.3 g/dL (95% CI -3.8 to -2.8 g/dL), and 6.9 g/dL (95% CI 6.4 to 7.4 g/dL), respectively. The intraclass correlation coefficient was 0.53 (estimated 95% CI 0.10 to 0.74). The number of potential errors about transfusion decision was 38 (13% of patients). The peripheral oxygen saturation and the true value of hemoglobin concentration were independently associated with the bias.


CONCLUSIONS
Results from this widely available noninvasive point-of-care hemoglobin monitoring device were systematically biased and too unreliable to guide transfusion decisions.
Clinical Epidemiology and Biostatistics, Institut National de la Sante et le Recherche Medicale U717, Saint-Louis Hospital, Paris, France. etienne.gayat@9online.fr
Etienne
E
Gayat
Antoine
A
Bodin
Caroline
C
Sportiello
Mireille
M
Boisson
Jean-François
JF
Dreyfus
Emmanuel
E
Mathieu
Marc
M
Fischler
D000328:Adult; D000368:Aged; D001785:Blood Gas Monitoring, Transcutaneous / Q000295:instrumentation / Q000592:standards; D001795:Blood Pressure Determination; D004636:Emergency Service, Hospital; D005260:Female; D006452:Hemoglobinometry / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems / Q000592:standards; D011674:Pulse
D006454:Hemoglobins