Healthy Volunteer Study to Assess Microcirculatory Function

Study Overview
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Brief Summary
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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
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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

Official Title
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Microscopic and Spectroscopic Examination of Skin Microcirculation in Healthy Individuals Using ODI Technology

Conditions
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Healthy

Intervention / Treatment
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* Device: ODI-Tech medical device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Examination with the ODI-Tech medical device<br>Diffuse reflectance spectroscopy (DRS) operating within the visible wavelength region will be used for the microvascular oxygen saturation and haematocrit measurements. Computer-assisted microscopy (CAM) will be used for recording frames of skin microcirculation. | Device: ODI-Tech medical device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Capillary Density (FCD) | Expressed as mean value | 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. | Day 1, 2 assessments, minimum 1 hour between | 
| Microvascular Oxygen Saturation (SmvO2) | Percent | Day 1, 2 assessments, minimum 1 hour between | 
| Heterogeneity of SmvO2 | [coefficient of variation] within the specific assessment and patient | Day 1, 2 assessments, minimum 1 hour between | 
| Tissue haematocrit (TH) | Percentage | Day 1, 2 assessments, minimum 1 hour between | 
| Heterogeneity of TH | [coefficient of variation] within the specific assessment and patient | Day 1, 2 assessments, minimum 1 hour between | 
| Visual assessment of capillary morphology | dilatation, elongation, microvascular bleedings | Day 1, 2 assessments, minimum 1 hour between | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE/ADE/SAE/SADE/DD | Descriptive as number of reported, graded | Day 1 | 
| Reproducibility | Variance of FCD, SmvO2 and its associated heterogeneity between measurements | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer