Abstract
BackgroundMeasurement of blood hemoglobin (Hb) concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for the patient and allows time saving in patient care. The aims of the present study were to assess the concordance of Hb levels obtained non-invasively with the Pronto-7 monitor (version 2.1.9, Masimo Corporation, Irvine, USA) or with the NBM-200MP monitor (Orsense, Nes Ziona, Israel) and the values obtained from the usual colorimetric method using blood samples and to determine the source of discordance.Methods and FindingsWe conducted two consecutive prospective open trials enrolling patients presenting in the emergency department of a university hospital. The first was designed to assess Pronto-7™ and the second NBM-200MP™. In each study, the main outcome measure was the agreement between both methods. Independent factors associated with the bias were determined using multiple linear regression. Three hundred patients were prospectively enrolled in each study. For Pronto-7™, the absolute mean difference was 0.56 g.L−1 (95% confidence interval [CI] 0.41 to 0.69) with an upper agreement limit at 2.94 g.L−1 (95% CI [2.70;3.19]), a lower agreement limit at -1.84 g.L−1 (95% CI [-2.08;-1.58]) and an intra-class correlation coefficient at 0.80 (95% CI [0.74;0.84]). The corresponding values for the NBM-200MP™ were 0.21 [0.02;0.39], 3.42 [3.10;3.74], -3.01 [-3.32;-2.69] and 0.69 [0.62;0.75]. Multivariate analysis showed that age and laboratory values of hemoglobin were independently associated with the bias when using Pronto-7™, while perfusion index and laboratory value of hemoglobin were independently associated with the bias when using NBM-200MP™.ConclusionDespite a relatively limited bias in both cases, the large limits of agreement found in both cases render the clinical usefulness of such devices debatable. For both devices, the bias is independently and inversely associated with the true value of hemoglobin.Trial RegistrationClinicalTrials.gov NCT01321580 NCT01321593
Highlights
After the introduction of pulse oximetry [1] which dramatically improved patient care, in acute conditions in the emergency room (ER), the recent development of devices allowing non-invasive and almost immediate measurement of hemoglobin (SpHb) is promising.blood hemoglobin is routinely assessed mainly for two purposes, to diagnose anemia, and to pursue more invasive testing, and to assess the need for blood transfusion
Despite a relatively limited bias in both cases, the large limits of agreement found in both cases render the clinical usefulness of such devices debatable
The cut-off values leading to the diagnosis of anemia are widely accepted [2,3] while the need for transfusion is decided after putting the hemoglobin value in the perspective of the clinical context of the patient
Summary
After the introduction of pulse oximetry [1] which dramatically improved patient care, in acute conditions in the emergency room (ER), the recent development of devices allowing non-invasive and almost immediate measurement of hemoglobin (SpHb) is promising.blood hemoglobin is routinely assessed mainly for two purposes, to diagnose anemia, and to pursue more invasive testing, and to assess the need for blood transfusion. The results of the four studies were discordant and in three cases [4,5] a relatively large discrepancy was reported between non-invasive measurements (SpHb) and classic measurement (Hb-Lab) Since these reports, in order to improve the accuracy of the non-invasive measurements, new monitors and probes have been developed. This new device, namely the NBM200MPTM (Orsense, Nes Ziona, Israel), uses differential light absorption before and after blood flow obstruction in a finger to determine hemoglobin level non-invasively. The aims of the present study were to assess the concordance of Hb levels obtained non-invasively with the Pronto-7 monitor (version 2.1.9, Masimo Corporation, Irvine, USA) or with the NBM-200MP monitor (Orsense, Nes Ziona, Israel) and the values obtained from the usual colorimetric method using blood samples and to determine the source of discordance
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