Evaluation of a New Noninvasive Device in Determining Hemoglobin Levels in Emergency Department Patients

Abstract

Introduction: The Masimo Radical-7 Pulse CO-Oximeter is a medical device recently approved by the US Food and Drug Administration that performs noninvasive oximetry and estimated venous or arterial hemoglobin measurements. A portable, noninvasive device that rapidly measures hemoglobin concentration could be useful in both austere and modern hospital settings. The objective of this study is to determine the degree of variation between the device's estimated hemoglobin measurement and the actual venous hemoglobin concentration in undifferentiated emergency department (ED) patients.Methods: We conducted a prospective, observational, cross-sectional study of adult patients presenting to the ED. The subjects consisted of a convenience sample of adult ED patients who required a complete blood count as part of their care in the ED. A simultaneous probe hemoglobin was obtained and recorded.Results: Bias between probe and laboratory hemoglobin measurements was –0.5 (95% confidence interval, – 0.8 to –0.1) but this was not statistically significant from 0 (t0.05,124 = 0.20, P > 0.5). The limits of agreement were –4.7 and 3.8, beyond the clinically relevant standard of equivalency of ± 1 g/dL.Conclusion: These data suggest that noninvasive hemoglobin determination is not sufficiently accurate for emergency department use.

Smartphone app for non-invasive detection of anemia using only patient-sourced photos

“…4b ). Furthermore, this degree of accuracy falls below a clinically significant threshold for Hgb level measurement of ±1 g dL −1 (95% LOA) 22 , 28 , 29 , suggesting that this system can potentially be considered interchangeable with the CBC Hgb level given further study and an increased sample size 30 . Furthermore, 93% of measurements fall within Clinical Laboratory Improvement Amendment (CLIA) allowable total error of ±7% (difference from CBC) 31 , indicating that, upon further refinement and completion of additional testing, this technology may potentially be viable for at-home and clinical use for diagnosis of anemia in addition to the screening capability of the app when uncalibrated.…”

Noninvasively Measured Hemoglobin Concentration Reflects Arterial Hemoglobin Concentration Before but Not After Cardiopulmonary Bypass in Patients Undergoing Coronary Artery or Valve Surgery

“…41 When using Bland-Altman analysis a considerable positive and negative biases with wide limits of agreement between SpHb and Hb have been reported in many previous studies. 19, 22, 24, 25, 27, 31, 32, 42 These data emphasize that the Radical-7’s usefulness may be limited for clinical decision making under a variety of conditions. Our findings confirm and extend these past results in an additional population, cardiac surgery patients.…”

“…Since its introduction on the market more than half a decade ago, non-invasive SpHb has been the focus of numerous studies in pediatric, 11–15 spine, 16–18 trauma, 19, 20 obstetric, 21–23 urological, 24 abdominal surgery, 25, 26 emergency, 27–29 critically ill 30–32 and other patient groups 33–40 as well as a few review articles. 1–3 …”

Point of Care Testing and Transfusion Safety in Resource Limited Settings: A Review

“…Noninvasive devices offer an appealing alternative for haemoglobin determination, however limitations in accuracy, especially in emergency situations such as hypovolemic shock, caution against their utilization as unique transfusion decision tools [24][25][26].…”