The aim of the study is to obtain microvascular data from a healthy, heterogeneous population for assessing reference values for the parameters Functional Capillary Density (FCD), heterogeneity of FCD, Microvascular Oxygen Saturation (SmvO2) and Heterogeneity of SmvO2 for healthy adults with respect to gender, age, and skin type (Fitzpatrick scale)
Primary objective: • Obtain reference data of the studied microvascular parameters in a healthy, heterogeneous population Secondary objectives: * Determine the reproducibility of the parameters obtained using the device produced by ODI Medical * Confirm the safety of the device produced by ODI Medical
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
112
The device captures and stores frames of the movement of blood in capillaries and spectra containing information on oxygen saturation. Proprietary software is used to analyse the obtained frames and spectra to calculate microvascular parameters such as functional capillary density and microvascular oxygen saturation. ODI-Tech can be brought to the patient's bedside and operates non-invasively. The device parts are in contact with the patient for less than 5 minutes.
ODI Medical
Oslo, Norway
Functional Capillary Density (FCD)
Expressed as mean value
Time frame: Day 1, 2 assessments, minimum 1 hour between
Heterogeneity of FCD
FCD from each frame is recorded from four quadrants in each frame where the coefficient of variation (CoV) in each frame is calculated, as well as an average CoV based on the 20 values from the same subject and session.
Time frame: Day 1, 2 assessments, minimum 1 hour between
Microvascular Oxygen Saturation (SmvO2)
Percent
Time frame: Day 1, 2 assessments, minimum 1 hour between
Heterogeneity of SmvO2
\[coefficient of variation\] within the specific assessment and patient
Time frame: Day 1, 2 assessments, minimum 1 hour between
Tissue haematocrit (TH)
Percentage
Time frame: Day 1, 2 assessments, minimum 1 hour between
Heterogeneity of TH
\[coefficient of variation\] within the specific assessment and patient
Time frame: Day 1, 2 assessments, minimum 1 hour between
Visual assessment of capillary morphology
dilatation, elongation, microvascular bleedings
Time frame: Day 1, 2 assessments, minimum 1 hour between
Incidence of AE/ADE/SAE/SADE/DD
Descriptive as number of reported, graded
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1
Reproducibility
Variance of FCD, SmvO2 and its associated heterogeneity between measurements
Time frame: Day 1