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...

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Bibliographic Details
Published in:Sensors (Basel, Switzerland) Switzerland), 2021-10, Vol.21 (21), p.6957
Main Authors: Cortese, Lorenzo, Zanoletti, Marta, Karadeniz, Umut, Pagliazzi, Marco, Yaqub, M. Atif, Busch, David R., Mesquida, Jaume, Durduran, Turgut
Format: Article
Language:English
Subjects:
Biomedical materials
Clinical trials
Continuous radiation
continuous wave near-infrared spectroscopy
Coronaviruses
COVID-19
Disease transmission
Forearm
Health care facilities
Hemodynamics
Hemoglobin
Hospitals
In vivo methods and tests
Infrared spectra
Infrared spectroscopy
Intensive care
light propagation in tissue
local tissue oxygenation
Measuring instruments
Medical equipment
medical optics
Medical research
multi-center clinical trial
Muscles
Near infrared radiation
Occlusion
Optical properties
Oxygen content
Oxygen saturation
Oxygenation
Pandemics
Performance evaluation
Reproducibility
Spectrum analysis
Standardization
Vascular occlusion
vascular occlusion test
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Summary: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,
ISSN:1424-8220
1424-8220
DOI:10.3390/s21216957