Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Examination with the ODI-Tech medical device | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODI-Tech medical device | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Knut Kvernebo, PhD, MD | ODI Medical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ODI Medical | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28632939 | Background | Sundheim LK, Sporastoyl AH, Wester T, Salerud G, Kvernebo K. Acute skin trauma induces hyperemia, but superficial papillary nutritive perfusion remains unchanged. Microcirculation. 2017 Oct;24(7). doi: 10.1111/micc.12389. | |
| 26854800 | Background | Fredly S, Fugelseth D, Nygaard CS, Salerud EG, Stiris T, Kvernebo K. Noninvasive assessments of oxygen delivery from the microcirculation to skin in hypothermia-treated asphyxiated newborn infants. Pediatr Res. 2016 Jun;79(6):902-6. doi: 10.1038/pr.2016.16. Epub 2016 Feb 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 |
| 15086539 | Background | Mork C, Salerud EG, Asker CL, Kvernebo K. The prostaglandin E1 analog misoprostol reduces symptoms and microvascular arteriovenous shunting in erythromelalgia-a double-blind, crossover, placebo-compared study. J Invest Dermatol. 2004 Mar;122(3):587-93. doi: 10.1111/j.0022-202X.2004.22339.x. |
| 23357861 | Background | Wester T, Awan ZA, Kvernebo TS, Salerud G, Kvernebo K. Skin microvascular morphology and hemodynamics during treatment with veno-arterial extra-corporeal membrane oxygenation. Clin Hemorheol Microcirc. 2014;56(2):119-31. doi: 10.3233/CH-131670. |
| 12406343 | Background | Mork C, Kvernebo K, Asker CL, Salerud EG. Reduced skin capillary density during attacks of erythromelalgia implies arteriovenous shunting as pathogenetic mechanism. J Invest Dermatol. 2002 Oct;119(4):949-53. doi: 10.1046/j.1523-1747.2002.00218.x. |
| 10733667 | Background | Mork C, Asker CL, Salerud EG, Kvernebo K. Microvascular arteriovenous shunting is a probable pathogenetic mechanism in erythromelalgia. J Invest Dermatol. 2000 Apr;114(4):643-6. doi: 10.1046/j.1523-1747.2000.00944.x. |
| 8812758 | Background | Staxrud LE, Jakobsson A, Kvernebo K, Salerud EG. Spatial and temporal evaluation of locally induced skin trauma recorded with laser Doppler techniques. Microvasc Res. 1996 Jan;51(1):69-79. doi: 10.1006/mvre.1996.0008. |
| 8608101 | Background | Bungum L, Kvernebo K, Oian P, Maltau JM. Laser doppler-recorded reactive hyperaemia in the forearm skin during the menstrual cycle. Br J Obstet Gynaecol. 1996 Jan;103(1):70-5. doi: 10.1111/j.1471-0528.1996.tb09517.x. |
| 24002120 | Background | Fredly S, Fugelseth D, Wester T, Haggblad E, Kvernebo K. Skin microcirculation in healthy term newborn infants--assessment of morphology, perfusion and oxygenation. Clin Hemorheol Microcirc. 2015;59(4):309-22. doi: 10.3233/CH-131764. |
| 21376735 | Background | Awan ZA, Haggblad E, Wester T, Kvernebo MS, Halvorsen PS, Kvernebo K. Diffuse reflectance spectroscopy: Systemic and microvascular oxygen saturation is linearly correlated and hypoxia leads to increased spatial heterogeneity of microvascular saturation. Microvasc Res. 2011 May;81(3):245-51. doi: 10.1016/j.mvr.2011.02.004. Epub 2011 Mar 2. |
| 33157128 | Background | Kvernebo AK, Miyamoto T, Sporastoyl AH, Wikslund LK, Masoy SE, Drolsum L, Moe MC, Salerud G, Fukamachi K, Kvernebo K. Quantification of ocular surface microcirculation by computer assisted video microscopy and diffuse reflectance spectroscopy. Exp Eye Res. 2020 Dec;201:108312. doi: 10.1016/j.exer.2020.108312. Epub 2020 Oct 22. |