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A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements

We describe the validation methodology for the NIRS based FORE-SIGHT ELITE(®) (CAS Medical Systems, Inc., Branford, CT, USA) tissue oximeter for cerebral and somatic tissue oxygen saturation (StO(2)) measurements for adult subjects submitted to the United States Food and Drug Administration (FDA) to...

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Autores principales: Benni, Paul B., MacLeod, David, Ikeda, Keita, Lin, Hung-Mo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838152/
https://www.ncbi.nlm.nih.gov/pubmed/28374103
http://dx.doi.org/10.1007/s10877-017-0015-1
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author Benni, Paul B.
MacLeod, David
Ikeda, Keita
Lin, Hung-Mo
author_facet Benni, Paul B.
MacLeod, David
Ikeda, Keita
Lin, Hung-Mo
author_sort Benni, Paul B.
collection PubMed
description We describe the validation methodology for the NIRS based FORE-SIGHT ELITE(®) (CAS Medical Systems, Inc., Branford, CT, USA) tissue oximeter for cerebral and somatic tissue oxygen saturation (StO(2)) measurements for adult subjects submitted to the United States Food and Drug Administration (FDA) to obtain clearance for clinical use. This validation methodology evolved from a history of NIRS validations in the literature and FDA recommended use of Deming regression and bootstrapping statistical validation methods. For cerebral validation, forehead cerebral StO(2) measurements were compared to a weighted 70:30 reference (REF CX(B)) of co-oximeter internal jugular venous and arterial blood saturation of healthy adult subjects during a controlled hypoxia sequence, with a sensor placed on the forehead. For somatic validation, somatic StO(2) measurements were compared to a weighted 70:30 reference (REF CX(S)) of co-oximetry central venous and arterial saturation values following a similar protocol, with sensors place on the flank, quadriceps muscle, and calf muscle. With informed consent, 25 subjects successfully completed the cerebral validation study. The bias and precision (1 SD) of cerebral StO(2) compared to REF CX(B) was −0.14 ± 3.07%. With informed consent, 24 subjects successfully completed the somatic validation study. The bias and precision of somatic StO(2) compared to REF CX(S) was 0.04 ± 4.22% from the average of flank, quadriceps, and calf StO(2) measurements to best represent the global whole body REF CX(S). The NIRS validation methods presented potentially provide a reliable means to test NIRS monitors and qualify them for clinical use.
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spelling pubmed-58381522018-03-09 A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements Benni, Paul B. MacLeod, David Ikeda, Keita Lin, Hung-Mo J Clin Monit Comput Original Research We describe the validation methodology for the NIRS based FORE-SIGHT ELITE(®) (CAS Medical Systems, Inc., Branford, CT, USA) tissue oximeter for cerebral and somatic tissue oxygen saturation (StO(2)) measurements for adult subjects submitted to the United States Food and Drug Administration (FDA) to obtain clearance for clinical use. This validation methodology evolved from a history of NIRS validations in the literature and FDA recommended use of Deming regression and bootstrapping statistical validation methods. For cerebral validation, forehead cerebral StO(2) measurements were compared to a weighted 70:30 reference (REF CX(B)) of co-oximeter internal jugular venous and arterial blood saturation of healthy adult subjects during a controlled hypoxia sequence, with a sensor placed on the forehead. For somatic validation, somatic StO(2) measurements were compared to a weighted 70:30 reference (REF CX(S)) of co-oximetry central venous and arterial saturation values following a similar protocol, with sensors place on the flank, quadriceps muscle, and calf muscle. With informed consent, 25 subjects successfully completed the cerebral validation study. The bias and precision (1 SD) of cerebral StO(2) compared to REF CX(B) was −0.14 ± 3.07%. With informed consent, 24 subjects successfully completed the somatic validation study. The bias and precision of somatic StO(2) compared to REF CX(S) was 0.04 ± 4.22% from the average of flank, quadriceps, and calf StO(2) measurements to best represent the global whole body REF CX(S). The NIRS validation methods presented potentially provide a reliable means to test NIRS monitors and qualify them for clinical use. Springer Netherlands 2017-04-03 2018 /pmc/articles/PMC5838152/ /pubmed/28374103 http://dx.doi.org/10.1007/s10877-017-0015-1 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research
Benni, Paul B.
MacLeod, David
Ikeda, Keita
Lin, Hung-Mo
A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title_full A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title_fullStr A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title_full_unstemmed A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title_short A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
title_sort validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838152/
https://www.ncbi.nlm.nih.gov/pubmed/28374103
http://dx.doi.org/10.1007/s10877-017-0015-1
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