TY - JOUR
T1 - Performance assessment of a commercial continuous-wave near-infrared spectroscopy tissue oximeter for suitability for use in an international, multi-center clinical trial
AU - Cortese, Lorenzo
AU - Zanoletti, Marta
AU - Karadeniz, Umut
AU - Pagliazzi, Marco
AU - Yaqub, M. Atif
AU - Busch, David R.
AU - Mesquida, Jaume
AU - Durduran, Turgut
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/11/1
Y1 - 2021/11/1
N2 - 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 multicenter trials but care must be taken to characterize, follow-up, and statistically account for inter-device variability.
AB - 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 multicenter trials but care must be taken to characterize, follow-up, and statistically account for inter-device variability.
KW - Continuous wave near-infrared spectroscopy
KW - Light propagation in tissue
KW - Local tissue oxygenation
KW - Medical optics
KW - Multicenter clinical trial
KW - Vascular occlusion test
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U2 - 10.3390/s21216957
DO - 10.3390/s21216957
M3 - Article
C2 - 34770264
AN - SCOPUS:85117336989
SN - 1424-8220
VL - 21
JO - Sensors
JF - Sensors
IS - 21
M1 - 6957
ER -