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

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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 (ARMS ≤ 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 (ARMS ≤ 1.7%). The use of monochromatic laser light sources can create a new generation of highly accurate, multi-parameter, pulse oximeters.

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Notes

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

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Funding

This work was performed, in part, with funding from the National Heart, Lung, and Blood Institute under SBIR grant HL073518.

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Authors and Affiliations

  1. Kestrel Labs, Inc., Research and Development, Boulder, CO, USA

    Jonas A. Pologe & Theodore P. Delianides

  2. Division of Emergency Medicine, Department of Pediatrics, Vanderbilt University School of Medicine, Vanderbilt Children’s Hospital, Nashville, TN, USA

    Donald H. Arnold

Authors
  1. Jonas A. Pologe
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  3. Theodore P. Delianides
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Contributions

JAP created the initial study design, conducted the study, performed the data analysis, and generated the first draft of the manuscript. DHA reviewed and edited the manuscript and provided input on the manuscript from a medical perspective. TPD reviewed the study design, conducted the study, and reviewed and edited the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jonas A. Pologe.

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Conflict of interest

Jonas A. Pologe is a founder and owner of Kestrel Labs, the company that developed NiCO™. Donald H. Arnold is on the medical advisory board for Kestrel Labs. There is no financial compensation for this position. Theodore P. Delianides is a founder and owner of Kestrel Labs, the company that developed NiCO™.

Ethical approval

The data collection methods utilized human blood that was procured from an American Association of Blood Banks (AABB) accredited blood bank (Vitalant, formerly Blood Systems Inc.), which provides de-identified samples. The proposed work was exempt from requiring Institutional Review Board approval per peer review by the assigned Scientific Review Group of the National Heart Lung and Blood Institute.

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Pologe, J.A., Arnold, D.H. & Delianides, T.P. Multi-analyte calibration and verification of a multi-parameter laser-based pulse oximeter. J Clin Monit Comput 36, 579–586 (2022). https://doi.org/10.1007/s10877-021-00704-1

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  • DOI: https://doi.org/10.1007/s10877-021-00704-1

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