Healthy Volunteer Study to Assess Microcirculatory Function

NCT05608798 | Completed

• 1 other identifier: CIV-NO-22-08-040389
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy

Keywords

Healthy volunteer

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Incidence of AE/ADE/SAE/SADE/DD

  Day 1

• Reproducibility

  Day 1

Study Arms (1)

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.

Device: ODI-Tech medical device

Interventions

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.

Examination with the ODI-Tech medical device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Regular smokers
• Misusers of alcohol
• Misusers of drugs
• Not intact skin or reddening in the region of interest

Sponsors & Collaborators

• ODI Medical AS: lead

Study Sites (1)

ODI Medical

Oslo, Norway

Location

Related Publications (11)

• 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.

  PMID: 28632939 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.

  PMID: 26854800 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.

  PMID: 15086539 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.

  PMID: 23357861 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.

  PMID: 12406343 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.

  PMID: 10733667 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.

  PMID: 8812758 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.

  PMID: 8608101 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.

  PMID: 24002120 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.

  PMID: 21376735 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.

  PMID: 33157128 BACKGROUND

Study Officials

• Knut Kvernebo, PhD, MD

  ODI Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 8, 2022
• Study Start: September 20, 2022
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

NO (1)