Evaluation of the robustness of cerebral oximetry to variations in skin pigmentation using a tissue-simulating phantom.

Autor:	Afshari A; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Saager RB; Linköping Univ., Dept. of Biomedical Engineering, Linköping, Sweden., Burgos D; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Vogt WC; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Wang J; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Mendoza G; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Weininger S; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA., Sung KB; National Taiwan University, Graduate Institute of Biomedical Electronics and Bioinformatics, Taipei, Taiwan., Durkin AJ; Department of Biomedical Engineering, University of California, Irvine, 3120 Natural Sciences II, Irvine, California 92697, USA.; Beckman Laser Institute & Medical Clinic, University of California, Irvine, 1002 Health Sciences Rd. East Irvine, California 92617, USA., Pfefer TJ; Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, USA.
Jazyk:	angličtina
Zdroj:	Biomedical optics express [Biomed Opt Express] 2022 Apr 21; Vol. 13 (5), pp. 2909-2928. Date of Electronic Publication: 2022 Apr 21 (Print Publication: 2022).
DOI:	10.1364/BOE.454020
Abstrakt:	Clinical studies have demonstrated that epidermal pigmentation level can affect cerebral oximetry measurements. To evaluate the robustness of these devices, we have developed a phantom-based test method that includes an epidermis-simulating layer with several melanin concentrations and a 3D-printed cerebrovascular module. Measurements were performed with neonatal, pediatric and adult sensors from two commercial oximeters, where neonatal probes had shorter source-detector separation distances. Referenced blood oxygenation levels ranged from 30 to 90%. Cerebral oximeter outputs exhibited a consistent decrease in saturation level with simulated melanin content; this effect was greatest at low saturation levels, producing a change of up to 15%. Dependence on pigmentation was strongest in a neonatal sensor, possibly due to its high reflectivity. Overall, our findings indicate that a modular channel-array phantom approach can provide a practical tool for assessing the impact of skin pigmentation on cerebral oximeter performance and that modifications to algorithms and/or instrumentation may be needed to mitigate pigmentation bias. Competing Interests: The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. This article reflects the views of the authors and should not be construed to represent FDA’s views or policies. (© 2022 Optica Publishing Group under the terms of the Optica Open Access Publishing Agreement.)
Databáze:	MEDLINE
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