Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies
Etienne Gayat, Jérôme Aulagnier, Emmanuel Matthieu, Mireille Boisson, Marc Fischler, Etienne Gayat, Jérôme Aulagnier, Emmanuel Matthieu, Mireille Boisson, Marc Fischler
Abstract
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 and NCT01321593.
Conflict of interest statement
Competing Interests: The authors have declared that no competing interests exist.
Figures
![Figure 1. Flow chart of the studies…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g001.jpg)
![Figure 2. Distribution of hemoglobin value in…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g002.jpg)
![Figure 3. Bland and Altman graphical representation…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g003.jpg)
![Figure 4. Association between true values of…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g004.jpg)
Figure 5. Association between perfusion index and…
Figure 5. Association between perfusion index and bias.
Results for the Pronto-Study are displayed on…
Figure 6. Three-dimensional representation of the variability…
Figure 6. Three-dimensional representation of the variability of the measures obtained with the two monitors.
- Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors.Gayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Gayat E, et al. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783. Anesth Analg. 2017. PMID: 28221201 Clinical Trial.
- Systematic review and meta-analysis of method comparison studies of Masimo pulse co-oximeters (Radical-7™ or Pronto-7™) and HemoCue® absorption spectrometers (B-Hemoglobin or 201+) with laboratory haemoglobin estimation.Hiscock R, Kumar D, Simmons SW. Hiscock R, et al. Anaesth Intensive Care. 2015 May;43(3):341-50. doi: 10.1177/0310057X1504300310. Anaesth Intensive Care. 2015. PMID: 25943608 Review.
- Accuracy of a continuous noninvasive hemoglobin monitor in intensive care unit patients.Frasca D, Dahyot-Fizelier C, Catherine K, Levrat Q, Debaene B, Mimoz O. Frasca D, et al. Crit Care Med. 2011 Oct;39(10):2277-82. doi: 10.1097/CCM.0b013e3182227e2d. Crit Care Med. 2011. PMID: 21666449
- Comparison of Massimo Pronto-7 and HemoCue Hb 201+ with laboratory haemoglobin estimation: a clinical study.Hiscock R, Simmons S, Carstensen B, Gurrin L. Hiscock R, et al. Anaesth Intensive Care. 2014 Sep;42(5):608-13. doi: 10.1177/0310057X1404200510. Anaesth Intensive Care. 2014. PMID: 25233174
- Accuracy of Point-of-Care Testing for Anemia in the Emergency Department.Osborn ZT, Villalba N, Derickson PR, Sewatsky TP, Wager AP, Freeman K. Osborn ZT, et al. Respir Care. 2019 Nov;64(11):1343-1350. doi: 10.4187/respcare.06364. Epub 2019 Mar 26. Respir Care. 2019. PMID: 30914492
- Smartphone-based point-of-care anemia screening in rural Bihar in India.Haggenmüller V, Bogler L, Weber AC, Kumar A, Bärnighausen T, Danquah I, Vollmer S. Haggenmüller V, et al. Commun Med (Lond). 2023 Mar 22;3(1):38. doi: 10.1038/s43856-023-00267-z. Commun Med (Lond). 2023. PMID: 36949164 Free PMC article.
- Non-invasive hemoglobin estimation for preoperative anemia screening.Hornedo-González KD, Jacob AK, Burt JM, Higgins AA, Engel EM, Hanson AC, Belch L, Kor DJ, Warner MA. Hornedo-González KD, et al. Transfusion. 2023 Feb;63(2):315-322. doi: 10.1111/trf.17237. Epub 2023 Jan 5. Transfusion. 2023. PMID: 36605019
- Evaluation of the usefulness of non-invasive serum haemoglobin measurement in a perioperative setting in a prospective observational study.Honnef G, Auinger D, Eichinger M, Eichlseder M, Metnitz PGH, Rief M, Zajic P, Zoidl P, Bornemann-Cimenti H. Honnef G, et al. Sci Rep. 2022 May 31;12(1):9065. doi: 10.1038/s41598-022-13285-z. Sci Rep. 2022. PMID: 35641593 Free PMC article.
- Continuous hemoglobin measurement during frontal advancement operations can improve patient outcomes.Saracoglu A, Abdullayev R, Sakar M, Sacak B, Girgin Incekoy F, Aykac Z. Saracoglu A, et al. J Clin Monit Comput. 2022 Dec;36(6):1689-1695. doi: 10.1007/s10877-022-00813-5. Epub 2022 Mar 7. J Clin Monit Comput. 2022. PMID: 35257263
- Derivation and external validation of a risk score for predicting HIV-associated tuberculosis to support case finding and preventive therapy scale-up: A cohort study.Auld AF, Kerkhoff AD, Hanifa Y, Wood R, Charalambous S, Liu Y, Agizew T, Mathoma A, Boyd R, Date A, Shiraishi RW, Bicego G, Mathebula-Modongo U, Alexander H, Serumola C, Rankgoane-Pono G, Pono P, Finlay A, Shepherd JC, Ellerbrock TV, Grant AD, Fielding K. Auld AF, et al. PLoS Med. 2021 Sep 7;18(9):e1003739. doi: 10.1371/journal.pmed.1003739. eCollection 2021 Sep. PLoS Med. 2021. PMID: 34491987 Free PMC article.
-
- Severinghaus JW, Astrup PB. History of blood gas analysis. VI. Oximetry. J Clin Monit. 1986;2:270–288. - PubMed
-
- Report of the WHO/UNICEF/UNU Consultation. Geneva, Switzerland: WHO (World Health Organization); 1994. Indicators and Strategies for Iron Deficiency and Anemia Programmes.
-
- Khusun H, Yip R, Schultink W, Dillon DH. World Health Organization hemoglobin cut-off points for the detection of anemia are valid for an Indonesian population. J Nutr. 1999;129:1669–1674. - PubMed
-
- Gayat E, Bodin A, Sportiello C, Boisson M, Dreyfus JF, et al. Performance Evaluation of a Noninvasive Hemoglobin Monitoring Device. Ann Emerg Med. 2011. - PubMed
-
- Hahn RG, Li Y, Zdolsek J. Non-invasive monitoring of blood haemoglobin for analysis of fluid volume kinetics. Acta Anaesthesiol Scand. 2010;54:1233–1240. - PubMed
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- Anxiety / diagnosis
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- Blood Specimen Collection / adverse effects
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- Monitoring, Physiologic / methods*
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- Hemoglobins
- ClinicalTrials.gov/NCT01321580
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![Figure 5. Association between perfusion index and…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g005.jpg)
Figure 6. Three-dimensional representation of the variability…
Figure 6. Three-dimensional representation of the variability of the measures obtained with the two monitors.
![Figure 6. Three-dimensional representation of the variability…](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/3253126/bin/pone.0030065.g006.jpg)
References
- Severinghaus JW, Astrup PB. History of blood gas analysis. VI. Oximetry. J Clin Monit. 1986;2:270–288.
- Report of the WHO/UNICEF/UNU Consultation. Geneva, Switzerland: WHO (World Health Organization); 1994. Indicators and Strategies for Iron Deficiency and Anemia Programmes.
- Khusun H, Yip R, Schultink W, Dillon DH. World Health Organization hemoglobin cut-off points for the detection of anemia are valid for an Indonesian population. J Nutr. 1999;129:1669–1674.
- Gayat E, Bodin A, Sportiello C, Boisson M, Dreyfus JF, et al. Performance Evaluation of a Noninvasive Hemoglobin Monitoring Device. Ann Emerg Med. 2011.
- Hahn RG, Li Y, Zdolsek J. Non-invasive monitoring of blood haemoglobin for analysis of fluid volume kinetics. Acta Anaesthesiol Scand. 2010;54:1233–1240.
- Macknet MR, Allard M, Applegate RL, 2nd, Rook J. The accuracy of noninvasive and continuous total hemoglobin measurement by pulse CO-Oximetry in human subjects undergoing hemodilution. Anesth Analg. 2010;111:1424–1426.
- Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011;112:858–863.
- Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Bmj. 2003;326:41–44.
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;1:307–310.
- Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest. 1999;59:491–500.
- Shoukri MM, Asyali MH, Donner A. Sample size requirements for the design of reliability study: review and new results. Statistical Methods in Medical Research. 2004;13:251–271.
- von Schenck H, Falkensson M, Lundberg B. Evaluation of “HemoCue,” a new device for determining hemoglobin. Clin Chem. 1986;32:526–529.
- Gayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011.
- Gehring H, Hornberger C, Dibbelt L, Rothsigkeit A, Gerlach K, et al. Accuracy of point-of-care-testing (POCT) for determining hemoglobin concentrations. Acta Anaesthesiol Scand. 2002;46:980–986.
- Lardi AM, Hirst C, Mortimer AJ, McCollum CN. Evaluation of the HemoCue for measuring intra-operative haemoglobin concentrations: a comparison with the Coulter Max-M. Anaesthesia. 1998;53:349–352.
Source: PubMed