Healthy
Conditions
Keywords
Healthy volunteer
Brief summary
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)
Detailed description
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
Interventions
DEVICEODI-Tech medical device
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.
Sponsors
ODI Medical AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \>18 * Subjects without signs or symptoms of acute or chronic disease and that are not treated with regular medication (contraceptive pills/IUD and oestrogen medication for menopausal symptoms are allowed). Pregnant women can be included.
Exclusion criteria
* Regular smokers * Misusers of alcohol * Misusers of drugs * Not intact skin or reddening in the region of interest
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual assessment of capillary morphology | Day 1, 2 assessments, minimum 1 hour between | dilatation, elongation, microvascular bleedings |
| Tissue haematocrit (TH) | Day 1, 2 assessments, minimum 1 hour between | Percentage |
| Heterogeneity of TH | Day 1, 2 assessments, minimum 1 hour between | \[coefficient of variation\] within the specific assessment and patient |
| Functional Capillary Density (FCD) | Day 1, 2 assessments, minimum 1 hour between | Expressed as mean value |
| Heterogeneity of FCD | Day 1, 2 assessments, minimum 1 hour between | 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. |
| Microvascular Oxygen Saturation (SmvO2) | Day 1, 2 assessments, minimum 1 hour between | Percent |
| Heterogeneity of SmvO2 | Day 1, 2 assessments, minimum 1 hour between | \[coefficient of variation\] within the specific assessment and patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility | Day 1 | Variance of FCD, SmvO2 and its associated heterogeneity between measurements |
| Incidence of AE/ADE/SAE/SADE/DD | Day 1 | Descriptive as number of reported, graded |
Countries
Norway
Outcome results
None listed