Top

Journal of Clinical Monitoring and Computing

Published in:

19-04-2021 | Laser | Original Research

Multi-analyte calibration and verification of a multi-parameter laser-based pulse oximeter

Authors: Jonas A. Pologe, Donald H. Arnold, Theodore P. Delianides

Published in: Journal of Clinical Monitoring and Computing | Issue 2/2022

Abstract

Almost since its introduction pulse oximetry was known to overestimate oxygen saturation in cases of carbon monoxide poisoning or elevated methemoglobin (metHb) levels. To eliminate this dangerous behavior some manufacturers have added additional LED emitters to try to increase the number of measured hemoglobin species and to improve measurement accuracy, but have not been very successful. We hypothesized that the use of narrow-band laser light sources would make accurate and precise measurement of the four primary species of hemoglobin possible, even in cases of elevated levels of carboxyhemoglobin (COHb). Calibration and verification studies were performed on a tissue simulator that employed an artificial finger pulsating with whole human blood. This simulator allowed safe generation of 165 different combinations of the levels of oxyhemoglobin (O₂Hb), COHb, metHb, and reduced hemoglobin (RHb) for calibration of the laser-based pulse oximeter. A follow-on study used 56 mixed hemoglobin levels for verification and statistical analysis of the performance of this device. This laser-based pulse oximeter measured all four species of hemoglobin accurately and precisely (A_RMS ≤ 1.8%) for metHb levels in the clinically normal range. At elevated metHb levels the device continued to provide accurate and precise measurements of metHb and RHb (A_RMS ≤ 1.7%). The use of monochromatic laser light sources can create a new generation of highly accurate, multi-parameter, pulse oximeters.

Because the invasive measurement of the given analyte is a precise reference (“gold standard”) value, the differences are plotted only against the reference.

BTl BIOX III, Operating/Service Manual, Rev A BTI: Boulder, CO; 1983

Ohmeda Biox, 3700 Pulse Oximeter, Operating/Maintenance Manual, Rev F. BOC Health Care: Boulder, CO; 1985

Barker SJ, Tremper KK. The effect of carbon monoxide inhalation on pulse oximetry and transcutaneous PO₂. Anesthesiology. 1987;66(5):677–9. https://doi.org/10.1097/00000542-198705000-00014.CrossRefPubMed

Barker SJ, Tremper KK, Hyatt J. Effects of methemoglobinemia on pulse oximetry and mixed venous oximetry. Anesthesiology. 1989;70(1):112–7. https://doi.org/10.1097/00000542-198901000-00021.CrossRefPubMed

CDC (2008) Nonfatal, Unintentional, Non--Fire-Related Carbon Monoxide Exposures --- United States, 2004--2006. CDC. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5733a2.htm. Accessed 16 Aug 2020

Bennetto L, Powter L, Scolding NJ. Accidental carbon monoxide poisoning presenting without a history of exposure: a case report. J Med Case Rep. 2008;2:118. https://doi.org/10.1186/1752-1947-2-118.CrossRefPubMedPubMedCentral

Hampson NB, Scott KL, Zmaeff JL. Carboxyhemoglobin measurement by hospitals: implications for the diagnosis of carbon monoxide poisoning. J Emerg Med. 2006;31(1):13–6. https://doi.org/10.1016/j.jemermed.2005.09.010.CrossRefPubMed

Reddy A, Lasher SC. Fuhrman TM Carbon monoxide poisoning and SpO₂: a case report. Internet J Anesthesiol. 2005. https://doi.org/10.5580/b4f.CrossRef

Roth D, Krammel M, Schreiber W, Herkner H, Havel C, Laggner AN. Unrecognized carbon monoxide poisoning leads to a multiple-casualty incident. J Emerg Med. 2013;45(4):559–61. https://doi.org/10.1016/j.jemermed.2013.05.003.CrossRefPubMed

10.

Grieb G, Simons D, Piatkowski A, Altiok E, Eppstein RJ, Bernhagen J, Pallua N. Carbon monoxide intoxication versus myocardial infarction: An easy diagnosis? Burns. 2011;37(4):e29-31. https://doi.org/10.1016/j.burns.2011.01.002.CrossRefPubMed

11.

Bessereau J, Heireche F, Bremond V, Boutin A, Petit S, Tsapis M, Boiron L, Puget A, Garry P, Coulange M, Kerbaul F. Response to: carbon monoxide poisoning cases presenting with non-specific symptoms by Deniz. Accuracy of triage with RAD-57 pulse CO-oximeter in suspected collective intoxication of a pediatric population. Toxicol Ind Health. 2018;34(5):361–3. https://doi.org/10.1177/0748233718756703.CrossRefPubMed

12.

Wolf SJ, Maloney GE, Shih RD, Shy BD, Brown MD. Clinical policy: critical issues in the evaluation and management of adult patients presenting to the emergency department with acute carbon monoxide poisoning. Ann Emerg Med. 2017;69(1):98–107. https://doi.org/10.1016/j.annemergmed.2016.11.003.CrossRefPubMed

13.

Rad-57 Operator’s Manual, Section 4 p. 5, Masimo Corporation: Irvine, CA; 2005

14.

Rad 87 Users Manual, p ii–iii, Masimo Corporation Irvine, CA 2008

15.

Clardy PF, Manaker S, Perry H (2020) Carbon monoxide poisoning-UpToDate. https://www.uptodate.com/contents/carbon-monoxide-poisoning. Accessed 16 Aug 2020

16.

O’Malley GF. Non-invasive carbon monoxide measurement is not accurate. Ann Emerg Med. 2006;48(4):477–8. https://doi.org/10.1016/j.annemergmed.2006.05.029.CrossRefPubMed

17.

Touger M, Birnbaum A, Wang J, Chou K, Pearson D, Bijur P. Performance of the RAD-57 pulse co-oximeter compared with standard laboratory carboxyhemoglobin measurement. Ann Emerg Med. 2010;56(4):382–8. https://doi.org/10.1016/j.annemergmed.2010.03.041.CrossRefPubMed

18.

Weaver LK, Churchill SK, Deru K, Cooney D. False positive rate of carbon monoxide saturation by pulse oximetry of emergency department patients. Respir Care. 2013;58(2):232–40. https://doi.org/10.4187/respcare.01744.CrossRefPubMed

19.

International Standard ISO 80601-2-61:2011, Clause 201.12.1, First edn., 2011

20.

International Standard. ISO 80601-2-61:2011, CC.2.5, First edn., 2011

21.

Nellcor™ Operators Manual, Bedside Respiratory Patient Monitoring System, Part No. 10104146 Rev E 2014–03, pp. 11–4 (2013). Covidien, Boulder, CO

22.

Rad 87 Users Manual, pp. 7–1, Masimo Corporation Irvine CA 2008

23.

Radical-7 Operator's Manual , vol 35322/LAB-5475F 0912, p 12. Masimo Corporation: Irvine, CA; 2012

24.

Reynolds KJ, Moyle JT, Sykes MK, Hahn CE. Response of 10 pulse oximeters to an in vitro test system. Br J Anaesth. 1992;68(4):365–9. https://doi.org/10.1093/bja/68.4.365.CrossRefPubMed

25.

Volgyesi GA, Kolesar R, Lerman J. A Simple Device for Testing Pulse Oximeters. Anesthesiology. 1990;73(3A):A427.

26.

Hornberger C, Knoop P, Matz H, Dorries F, Konecny E, Gehring H, Otten J, Bonk R, Frankenberger H, Wouters P, Gil-Rodriguez J, Ponz L, Avgerinos J, Karoutis A, Ikiades A, Weininger S. A prototype device for standardized calibration of pulse oximeters II. J Clin Monit Comput. 2002;17(3–4):203–9. https://doi.org/10.1023/a:1020795307742.CrossRefPubMed

Title: Multi-analyte calibration and verification of a multi-parameter laser-based pulse oximeter
Authors: Jonas A. Pologe
Donald H. Arnold
Theodore P. Delianides
Publication date: 19-04-2021
Publisher: Springer Netherlands
Keyword: Laser
Published in: Journal of Clinical Monitoring and Computing / Issue 2/2022
Print ISSN: 1387-1307
Electronic ISSN: 1573-2614
DOI: https://doi.org/10.1007/s10877-021-00704-1

At a glance: The STEP trials

Springer Medicine

Multi-analyte calibration and verification of a multi-parameter laser-based pulse oximeter

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 2/2022

Clinical evaluation of a novel subcutaneous lactate monitor

Extravascular leakage of induction doses of rocuronium: four cases in which both depth of neuromuscular block and plasma concentration of rocuronium were assessed

Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI)

What is new in microcirculation and tissue oxygenation monitoring?

Efficacy of intraoperative bulbocavernosus reflex monitoring for the prediction of postoperative voiding function in adult patients with lumbosacral spinal tumor

What is new in airway management