Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy. |
Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. The data for analysis will be equally distributed across the SpO2 range of 70-100%. |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of anion superoxide (µmol/min) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of lipids peroxidation (µg/mL) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of protein carbonylation (ng/mL) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of catalase (U/mg protein) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of superoxide dismutase (U/mg protein) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Descriptive kinetic of circulating oxidative stress markers under hypoxia conditions |
comparison of circulating oxidative stress and plasma antioxidant activity markers in blood between hypoxia and normal oxygenation conditions by dosage of glutathione (µmol/g protein) |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
Comparison of Mitochondrial respiration from PBMCs between hypoxia and normal oxygenation conditions. |
Mitochondrial respiration from PBMCs is assessed by high-resolution respirometry by analysis of the kinetic of the respirometry results and comparison between each hypoxia /post-hypoxia data point with the baseline. |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
To evaluate the impact of skin pigmentation on SpO2 determination by the MultiSense® solution. |
Comparison of the MultiSense® SpO2 performances with the reference between light and dark-pigmented subjects. Qualitative comparison of the raw PPG signal between light and dark-pigmented skin subjects. |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
To evaluate pulse transit time (PTT) as an indicator of blood pressure (BP) variation. |
Comparison of blood pressure variation measured by a standard cuff device with PTT variation measured by the MultiSense® acquisition system. |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
To evaluate the reliability of the respiration rate determined by the MultiSense® solution |
Determination of the quality of respiration rate provided by the MultiSense® patch in comparison to measurements made with reference medical devices in the hospital setting, in terms of accuracy. Accuracy is defined as an average measurement variation less than 5% of the respiration rate mean value to the reference standard. |
from patch placement to patch removal, assessed up to 3 hours |
|
Secondary |
To compare the quality of MultiSense® data from a patch worn on the chest and from a patch worn on the upper back in different body posture and to evaluate the impact of strip exact localization on the chest. |
Qualitative comparison of the raw PPG signal between the two patches location for each subject (chest and back). Comparison of the SpO2 derived by each MultiSense® patch to the reference during the resting period in different lying positions (supine, prone, left and right side). |
from patch placement to patch removal, assessed up to 3 hours |
|