Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial

Despite the wide range of clinical and research applications, the reliability of the absolute oxygenation measurements of continuous wave near-infrared spectroscopy sensors is often questioned, partially due to issues of standardization. In this study, we have compared the performances of 13 units o...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Lorenzo Cortese, Marta Zanoletti, Umut Karadeniz, Marco Pagliazzi, M. Atif Yaqub, David R. Busch, Jaume Mesquida, Turgut Durduran
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	continuous wave near-infrared spectroscopy vascular occlusion test local tissue oxygenation multi-center clinical trial medical optics light propagation in tissue Chemical technology TP1-1185
Acceso en línea:	https://doaj.org/article/210dd73945f74c09bb0a9173eba1f195
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:210dd73945f74c09bb0a9173eba1f195
record_format	dspace
spelling	oai:doaj.org-article:210dd73945f74c09bb0a9173eba1f1952021-11-11T19:00:20ZPerformance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial10.3390/s212169571424-8220https://doaj.org/article/210dd73945f74c09bb0a9173eba1f1952021-10-01T00:00:00Zhttps://www.mdpi.com/1424-8220/21/21/6957https://doaj.org/toc/1424-8220Despite the wide range of clinical and research applications, the reliability of the absolute oxygenation measurements of continuous wave near-infrared spectroscopy sensors is often questioned, partially due to issues of standardization. In this study, we have compared the performances of 13 units of a continuous wave near-infrared spectroscopy device (PortaMon, Artinis Medical Systems, NL) to test their suitability for being used in the HEMOCOVID-19 clinical trial in 10 medical centers around the world. Detailed phantom and in vivo tests were employed to measure the precision and reproducibility of measurements of local blood oxygen saturation and total hemoglobin concentration under different conditions: for different devices used, different operators, for probe repositioning over the same location, and over time (hours/days/months). We have detected systematic differences between devices when measuring phantoms (inter-device variability, <4%), which were larger than the intra-device variability (<1%). This intrinsic variability is in addition to the variability during in vivo measurements on the forearm muscle resulting from errors in probe positioning and intrinsic physiological noise (<9%), which was also larger than the inter-device differences (<3%) during the same test. Lastly, we have tested the reproducibility of the protocol of the HEMOCOVID-19 clinical trial; that is, forearm muscle oxygenation monitoring during vascular occlusion tests over days. Overall, our conclusion is that these devices can be used in multi-center trials but care must be taken to characterize, follow-up, and statistically account for inter-device variability.Lorenzo CorteseMarta ZanolettiUmut KaradenizMarco PagliazziM. Atif YaqubDavid R. BuschJaume MesquidaTurgut DurduranMDPI AGarticlecontinuous wave near-infrared spectroscopyvascular occlusion testlocal tissue oxygenationmulti-center clinical trialmedical opticslight propagation in tissueChemical technologyTP1-1185ENSensors, Vol 21, Iss 6957, p 6957 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	continuous wave near-infrared spectroscopy vascular occlusion test local tissue oxygenation multi-center clinical trial medical optics light propagation in tissue Chemical technology TP1-1185
spellingShingle	continuous wave near-infrared spectroscopy vascular occlusion test local tissue oxygenation multi-center clinical trial medical optics light propagation in tissue Chemical technology TP1-1185 Lorenzo Cortese Marta Zanoletti Umut Karadeniz Marco Pagliazzi M. Atif Yaqub David R. Busch Jaume Mesquida Turgut Durduran Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
description	Despite the wide range of clinical and research applications, the reliability of the absolute oxygenation measurements of continuous wave near-infrared spectroscopy sensors is often questioned, partially due to issues of standardization. In this study, we have compared the performances of 13 units of a continuous wave near-infrared spectroscopy device (PortaMon, Artinis Medical Systems, NL) to test their suitability for being used in the HEMOCOVID-19 clinical trial in 10 medical centers around the world. Detailed phantom and in vivo tests were employed to measure the precision and reproducibility of measurements of local blood oxygen saturation and total hemoglobin concentration under different conditions: for different devices used, different operators, for probe repositioning over the same location, and over time (hours/days/months). We have detected systematic differences between devices when measuring phantoms (inter-device variability, <4%), which were larger than the intra-device variability (<1%). This intrinsic variability is in addition to the variability during in vivo measurements on the forearm muscle resulting from errors in probe positioning and intrinsic physiological noise (<9%), which was also larger than the inter-device differences (<3%) during the same test. Lastly, we have tested the reproducibility of the protocol of the HEMOCOVID-19 clinical trial; that is, forearm muscle oxygenation monitoring during vascular occlusion tests over days. Overall, our conclusion is that these devices can be used in multi-center trials but care must be taken to characterize, follow-up, and statistically account for inter-device variability.
format	article
author	Lorenzo Cortese Marta Zanoletti Umut Karadeniz Marco Pagliazzi M. Atif Yaqub David R. Busch Jaume Mesquida Turgut Durduran
author_facet	Lorenzo Cortese Marta Zanoletti Umut Karadeniz Marco Pagliazzi M. Atif Yaqub David R. Busch Jaume Mesquida Turgut Durduran
author_sort	Lorenzo Cortese
title	Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
title_short	Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
title_full	Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
title_fullStr	Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
title_full_unstemmed	Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial
title_sort	performance assessment of a commercial continuous-wave near-infrared spectroscopy tissue oximeter for suitability for use in an international, multi-center clinical trial
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/210dd73945f74c09bb0a9173eba1f195
work_keys_str_mv	AT lorenzocortese performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT martazanoletti performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT umutkaradeniz performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT marcopagliazzi performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT matifyaqub performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT davidrbusch performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT jaumemesquida performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial AT turgutdurduran performanceassessmentofacommercialcontinuouswavenearinfraredspectroscopytissueoximeterforsuitabilityforuseinaninternationalmulticenterclinicaltrial
_version_	1718431631307440128

Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial

Ejemplares similares