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Performance Assessment of a Commercial Continuous-Wave Near-Infrared Spectroscopy Tissue Oximeter for Suitability for Use in an International, Multi-Center Clinical Trial.
Cortese, Lorenzo; Zanoletti, Marta; Karadeniz, Umut; Pagliazzi, Marco; Yaqub, M Atif; Busch, David R; Mesquida, Jaume; Durduran, Turgut.
  • Cortese L; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
  • Zanoletti M; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
  • Karadeniz U; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
  • Pagliazzi M; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
  • Yaqub MA; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
  • Busch DR; Department of Anesthesiology and Pain Management and Department of Neurology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.
  • Mesquida J; Àrea de Crítics, Parc Taulí Hospital Universitari, 08208 Sabadell, Spain.
  • Durduran T; ICFO-Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, 08860 Castelldefels, Spain.
Sensors (Basel) ; 21(21)2021 Oct 20.
Article in English | MEDLINE | ID: covidwho-1512555
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Oximetry / Spectroscopy, Near-Infrared Type of study: Clinical Practice Guide / Randomized controlled trials Language: English Year: 2021 Document Type: Article Affiliation country: S21216957

Full text: Available Collection: International databases Database: MEDLINE Main subject: Oximetry / Spectroscopy, Near-Infrared Type of study: Clinical Practice Guide / Randomized controlled trials Language: English Year: 2021 Document Type: Article Affiliation country: S21216957