Non-Invasive Measurement of Hemoglobin: Assessment of Two Different Point-of-Care Technologies

Measurement 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 w...

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Published inPloS one Vol. 7; no. 1; p. e30065
Main Authors Gayat, Etienne, Aulagnier, Jérôme, Matthieu, Emmanuel, Boisson, Mireille, Fischler, Marc
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 06.01.2012
Public Library of Science (PLoS)
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Online AccessGet full text
ISSN1932-6203
1932-6203
DOI10.1371/journal.pone.0030065

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Abstract Measurement 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. We 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™. 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin. ClinicalTrials.gov NCT01321580 and NCT01321593.
AbstractList Measurement 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. We 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™. 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin. ClinicalTrials.gov NCT01321580 and NCT01321593.
Measurement 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.We 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™.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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin.ClinicalTrials.gov NCT01321580 and NCT01321593.
Measurement 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. We 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[TM] and the second NBM-200MP[TM]. 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[TM], the absolute mean difference was 0.56 g.L.sup.-1 (95% confidence interval [CI] 0.41 to 0.69) with an upper agreement limit at 2.94 g.L.sup.-1 (95% CI [2.70;3.19]), a lower agreement limit at -1.84 g.L.sup.-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[TM] 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[TM], while perfusion index and laboratory value of hemoglobin were independently associated with the bias when using NBM-200MP[TM]. 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin.
Measurement 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.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.We 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™.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™.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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin.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.ClinicalTrials.gov NCT01321580 and NCT01321593.TRIAL REGISTRATIONClinicalTrials.gov NCT01321580 and NCT01321593.
Background Measurement 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 Findings We 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[TM] and the second NBM-200MP[TM]. 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[TM], the absolute mean difference was 0.56 g.L.sup.-1 (95% confidence interval [CI] 0.41 to 0.69) with an upper agreement limit at 2.94 g.L.sup.-1 (95% CI [2.70;3.19]), a lower agreement limit at -1.84 g.L.sup.-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[TM] 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[TM], while perfusion index and laboratory value of hemoglobin were independently associated with the bias when using NBM-200MP[TM]. Conclusion 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin. Trial Registration ClinicalTrials.gov NCT01321580 NCT01321593
Background Measurement 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 Findings We 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™. Conclusion 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin. Trial Registration ClinicalTrials.gov NCT01321580 NCT01321593
Background Measurement 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 Findings We 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™. Conclusion 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. For both devices, the bias is independently and inversely associated with the true value of hemoglobin. Trial Registration ClinicalTrials.gov NCT01321580 NCT01321593
Audience Academic
Author Fischler, Marc
Gayat, Etienne
Boisson, Mireille
Aulagnier, Jérôme
Matthieu, Emmanuel
AuthorAffiliation University of Colorado Denver, United States of America
2 Clinical Epidemiology and Biostatistics, INSERM U717, Saint-Louis Hospital, Paris, France
3 Emergency room, Foch Hospital, Suresnes, France
1 Department of Anesthesia, Foch Hospital, Suresnes, France
4 Department of Biology, Foch Hospital, Suresnes, France
AuthorAffiliation_xml – name: 4 Department of Biology, Foch Hospital, Suresnes, France
– name: 3 Emergency room, Foch Hospital, Suresnes, France
– name: University of Colorado Denver, United States of America
– name: 2 Clinical Epidemiology and Biostatistics, INSERM U717, Saint-Louis Hospital, Paris, France
– name: 1 Department of Anesthesia, Foch Hospital, Suresnes, France
Author_xml – sequence: 1
  givenname: Etienne
  surname: Gayat
  fullname: Gayat, Etienne
– sequence: 2
  givenname: Jérôme
  surname: Aulagnier
  fullname: Aulagnier, Jérôme
– sequence: 3
  givenname: Emmanuel
  surname: Matthieu
  fullname: Matthieu, Emmanuel
– sequence: 4
  givenname: Mireille
  surname: Boisson
  fullname: Boisson, Mireille
– sequence: 5
  givenname: Marc
  surname: Fischler
  fullname: Fischler, Marc
BackLink https://www.ncbi.nlm.nih.gov/pubmed/22238693$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright COPYRIGHT 2012 Public Library of Science
2012 Gayat et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
Gayat et al. 2012
Copyright_xml – notice: COPYRIGHT 2012 Public Library of Science
– notice: 2012 Gayat et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
– notice: Gayat et al. 2012
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Conceived and designed the experiments: EG MF. Performed the experiments: JA EM MB. Analyzed the data: EG. Contributed reagents/materials/analysis tools: MB MF. Wrote the paper: EG MF.
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Snippet Measurement of blood hemoglobin (Hb) concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for the...
Background Measurement of blood hemoglobin (Hb) concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for...
Background Measurement of blood hemoglobin (Hb) concentration is a routine procedure. Using a non-invasive point-of-care device reduces pain and discomfort for...
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SubjectTerms Accuracy
Adult
Aged
Algorithms
Analysis
Anemia
Anxiety - diagnosis
Anxiety - etiology
Bias
Biological variation
Biology
Blood
Blood levels
Blood Specimen Collection - adverse effects
Blood Specimen Collection - methods
Blood Specimen Collection - psychology
Blood Specimen Collection - statistics & numerical data
Chemistry
Clinical trials
Colorimetry
Confidence intervals
Correlation coefficient
Correlation coefficients
Discordance
Emergency medical care
Emergency medical services
Female
Glycosylated hemoglobin
Hemoglobin
Hemoglobins - analysis
Hospitalization - statistics & numerical data
Human subjects
Humans
Laboratories
Male
Measurement
Medical research
Medicine
Middle Aged
Minimally Invasive Surgical Procedures - adverse effects
Minimally Invasive Surgical Procedures - psychology
Minimally Invasive Surgical Procedures - statistics & numerical data
Monitoring, Physiologic - methods
Multivariate analysis
Pain
Pain Measurement
Patient care
Patients
Perfusion
Point-of-Care Systems
Political aspects
Regression analysis
Statistical analysis
Statistical methods
Studies
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Title Non-Invasive Measurement of Hemoglobin: Assessment of Two Different Point-of-Care Technologies
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