In the current study, we perform the metrological characterization of the device called IPAM which is a non-contact optical device for the measurement of skin (cutaneous) oxygen saturation rate (ScO2) in the framework of critical limb ischemia. IPAM reflectance measurement is sensitive to the differential absorption spectra of oxy- and deoxyhemoglobin. Spectrophotometry was chosen as the gold standard method to measure the oxygen saturation rate of hemoglobin solutions: results validate the fact that the IPAM device is sensitive to the modification of hemoglobin oxygen saturation rate but also that it is able of measuring the same orders of magnitude of variations as the gold standard method. The metrological characterization on seven healthy volunteers showed that the IPAM device measurement precision is 0.83. Intra-individual variability was measured as significant for four out of the seven healthy volunteers. Inter-individual variability was proven to be statistically significant and ambient light showed no impact on the ScO2 measurements performed by the IPAM device. Such results will have to be taken into account in order to correctly interpret clinical data that will be acquired during a future clinical study: only variation of measurements greater than 0.83 will be interpreted as significant, measurements may be performed in any lighting environment (natural or artificial light, low or high-lighting environments) and data can be interpreted (e.g. as “normal” or “low” oxygen saturation rate) only in comparison with a reference skin zone from the same patient.
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