Clinical evaluation of a novel technology for non‐invasive and continuous measurement of plasma haemoglobin concentration

Broderick, Alan; Desmond, Fiona; Leen, Gabriel; Shorten, G.

doi:10.1111/anae.13146

Cited by 11 publications

(15 citation statements)

References 13 publications

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“…We thank Geoghegan for his interest in our study [1]. However, as we did not study the Radical-7 pulse CO-oximeter (Masimo Corporation, Irvine, CA), we did not observe an upper limit of agreement of approximately 7 g.dL À1 between it and a laboratory reference method.…”

Section: Radical-7 Pulse Co-oximetrya Replymentioning

confidence: 83%

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

Kumar

Simmons

2015

Anaesth Intensive Care

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We assessed agreement in haemoglobin measurement between Masimo pulse co-oximeters (Rad-7™ and Pronto-7™) and HemoCue® photometers (201+ or B-Hemoglobin) with laboratory-based determination and identified 39 relevant studies (2915 patients in Masimo group and 3084 patients in HemoCue group). In the Masimo group, the overall mean difference was -0.03 g/dl (95% prediction interval -0.30 to 0.23) and 95% limits of agreement -3.0 to 2.9 g/dl compared to 0.08 g/dl (95% prediction interval -0.04 to 0.20) and 95% limits of agreement -1.3 to 1.4 g/dl in the HemoCue group. Only B-Hemoglobin exhibited bias (0.53, 95% prediction interval 0.27 to 0.78). The overall standard deviation of difference was larger (1.42 g/dl versus 0.64 g/dl) for Masimo pulse co-oximeters compared to HemoCue photometers. Masimo devices and HemoCue 201+ both provide an unbiased, pooled estimate of laboratory haemoglobin. However, Masimo devices have lower precision and wider 95% limits of agreement than HemoCue devices. Clinicians should carefully consider these limits of agreement before basing transfusion or other clinical decisions on these point-of-care measurements alone.

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Section: Radical-7 Pulse Co-oximetrya Replymentioning

confidence: 83%

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

Kumar

Simmons

2015

Anaesth Intensive Care

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“…42 reported a different analyzer (IPOC-1) having a lower mean Hb concentration (4.9 g/L). Spielmann et al, 138 Broderick et al., 43 and Zatloukal et al 106 analyzed venous blood by clinical laboratory blood gas analyzers compared with the reference in five comparisons. Broderick et al .…”

Section: Resultsmentioning

confidence: 99%

“…Spielmann et al found two different clinical blood gas analyzers (CBGA-1 and CBGA-2) to have a higher mean Hb concentration (5.8–8.0 g/L) and one analyzer (CBGA-3) to have a lower mean Hb concentration (0.5 g/L) compared with the reference. 138 When applying the mean concentration difference threshold of ±7% for the studies comparing the other portable photometric invasive POC analyzers or clinical laboratory blood gas analyzers with the reference, 11 studies including 17 comparisons 18,31,43,102,106,110,113,120,121,138 met the allowable degree of variation with one study exceeding the ±7% bias 42 (Fig. 4).…”

Section: Resultsmentioning

confidence: 99%

“…24,25,34 Due to a need for a noninvasive device to assess Hb, noninvasive POC analyzers were developed for use in more controlled settings, with the potential for use in field settings. [40][41][42][43][44] In 2006, Masimo was one of the first to develop noninvasive POC analyzers (Radical-7) followed by other model analyzers (and Pronto-7 pulse CO-oximeters) and companies, including Biosense (ToucHb) in 2008. These noninvasive POC analyzers operate using a device called the CO-oximeter, which measures the oxygen saturation (SpO 2 ), pulse rate, perfusion index (Pi), and total Hb by detecting the levels of oxygen and carbon monoxide (CO) bound to Hb in the individual.…”

Section: Description Of Methods and Analyzers To Assess Hb Concentratmentioning

confidence: 99%

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Methods and analyzers for hemoglobin measurement in clinical laboratories and field settings

Whitehead

Mei

Mapango

et al. 2019

Annals of the New York Academy of Sciences

123

100

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This paper describes and compares methods and analyzers used to measure hemoglobin (Hb) in clinical laboratories and field settings. We conducted a literature review for methods used to measure Hb in clinical laboratories and field settings. We described methods to measure Hb and factors influencing results. Automated hematology analyzer (AHA) was reference for all Hb comparisons using evaluation criteria of ±7% set by College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). Capillary fingerprick blood usually produces higher Hb concentrations compared with venous blood. Individual drops produced lower concentrations than pooled capillary blood. Compared with the AHA: (1) overall cyanmethemoglobin (1.0–8.0 g/L), WHO Colour Scale (0.5–10.0 g/L), paper-based devices (5.0–7.0 g/L), HemoCue® Hb-201 (1.0–16.0 g/L) and Hb-301 (0.5–6.0 g/L), and Masimo Pronto® (0.3–14.0 g/L) overestimated concentrations; (2) Masimo Radical® −7 both under- and overestimated concentrations (0.3–104.0 g/L); and (3) other methods underestimated concentrations (2.0–16.0 g/L). Most mean concentration comparisons varied less than ±7% of the reference. Hb measurements are influenced by several analytical factors. With few exceptions, mean concentration bias was within ±7%, suggesting acceptable performance. Appropriate, high-quality methods in all settings are necessary to ensure the accuracy of Hb measurements.This paper describes and compares methods and analyzers used to measure hemoglobin (Hb) in clinical laboratories and field settings. With few exceptions, mean concentration bias was within ±7%, suggesting acceptable performance. Appropriate, high-quality methods in all settings are necessary to ensure the accuracy of Hb measurements.

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“…Continuous non-invasive hemoglobin monitoring may also help identify whether acute decreases in hemoglobin are an early diagnostic marker of NEC, rather than causal risk factor. However, recent adult studies highlight the need for new research before non-invasive hemoglobin assessment can replace current invasive laboratory testing [38]. …”

Section: Hemovigilance and Rbc Transfusion-relevant Outcomesmentioning

confidence: 99%

Research Opportunities to Improve Neonatal Red Blood Cell Transfusion

Patel

Meyer

Widness

2016

Transfusion Medicine Reviews

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Red blood cell (RBC) transfusion is a common and lifesaving therapy for anemic neonates and infants, particularly among those born prematurely or undergoing surgery. However, evidence-based indications for when to administer RBCs and adverse effects of RBC transfusion on important outcomes including necrotizing enterocolitis, survival and long-term neurodevelopmental impairment remain uncertain. In addition, blood-banking practices for preterm and term neonates and infants have been largely developed using studies from older children and adults. Use of and refinements in emerging technologies and advances in biomarker discovery and neonatal-specific RBC transfusion databases may allow clinicians to better define and tailor RBC transfusion needs and practices to individual neonates. Decreasing the need for RBC transfusion and developing neonatal-specific approaches in the preparation of donor RBCs has potential for reducing resource utilization and cost, improving outcomes, and assuring blood safety. Finally, large donor-recipient linked cohort studies can provide data to better understand the balance of the risks and benefits of RBC transfusion in neonates. These studies may also guide the translation of new research into best practices that can rapidly be integrated into routine care. This review highlights key opportunities in transfusion medicine and neonatology for improving the preparation and transfusion of RBCs into neonates and infants. We focus on timely, currently addressable knowledge gaps that can increase the safety and efficacy of preterm and term neonatal and infant RBC transfusion practices.

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Clinical evaluation of a novel technology for non‐invasive and continuous measurement of plasma haemoglobin concentration

Cited by 11 publications

References 13 publications

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

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

Methods and analyzers for hemoglobin measurement in clinical laboratories and field settings

Research Opportunities to Improve Neonatal Red Blood Cell Transfusion

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Clinical evaluation of a novel technology for non‐invasive and continuous measurement of plasma haemoglobin concentration

Cited by 11 publications

References 13 publications

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

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

Methods and analyzers for hemoglobin measurement in clinical laboratories and field settings

Research Opportunities to Improve Neonatal Red Blood Cell Transfusion

Contact Info

Product

Resources

About

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

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