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Clinical Trials/NCT05324228
NCT05324228
Completed
Not Applicable

Determination of Reference Values for Sublingual Microcirculation in Healthy Volunteers in the Pediatric Population Using the Sidestream Dark-Field Imaging Method

Vlasta Krausová1 site in 1 country40 target enrollmentDecember 3, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Vlasta Krausová
Enrollment
40
Locations
1
Primary Endpoint
Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The main goal of the study is to determine the physiological parameters of sublingual microcirculation in children in different age categories using Sidestream Dark-Field Imaging Method. No significant differences are expected to be found between measurements in healthy volunteers in different age categories.

Detailed Description

After recording the basic anthropometric parameters, pressure, pulse and O2 saturation, each volunteer who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal in the afternoon, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.

Registry
clinicaltrials.gov
Start Date
December 3, 2021
End Date
September 16, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Vlasta Krausová
Responsible Party
Sponsor Investigator
Principal Investigator

Vlasta Krausová

Principal Investigator

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Eligibility Criteria

Inclusion Criteria

  • healthy child
  • informed consent of parents

Exclusion Criteria

  • inability to cooperate
  • acute illness
  • chronic illness
  • chronic medication
  • substance abuse

Outcomes

Primary Outcomes

Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children

Time Frame: baseline

The proportion of perfused small vessels (PPV \[%\]) can be calculated as follows: 100 × (total number of small vessels - \[no flow + intermittent flow\])/total number of small vessels. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

Determination of Perfused Vessel Density (all) of sublingual microcirculation of children

Time Frame: baseline

Total length of vessels - (no flow + intermittent flow) divided by total surface of area

Determination of Total Vascular Density of sublingual microcirculation of children

Time Frame: baseline

Total length of vessels divided by total surface of area

Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children

Time Frame: baseline

The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

Determination of Small Vessel Density of sublingual microcirculation of children

Time Frame: baseline

Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of children

Time Frame: baseline

Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).

Determination of DeBacker Score of sublingual microcirculation of children

Time Frame: baseline

In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines.

Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children

Time Frame: baseline

The proportion of perfused vessels (PPV \[%\]) can be calculated as follows: 100 × (total number of vessels - \[no flow + intermittent flow\])/total number of vessels.

Secondary Outcomes

  • Differences in Proportion of Perfused Vessels (all) in children of different age categories(baseline)
  • Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories(baseline)
  • Differences in Small Vessel Density in children of different age categories(baseline)
  • Differences in Perfused Small Vessel Density (PVD) in children of different age categories(baseline)
  • Differences in Microvascular Flow Index (MFI) in children of different age categories(baseline)
  • Differences in Perfused Vessel Density (all) in children of different age categories(baseline)
  • Differences in Total Vascular Density in children of different age categories(baseline)
  • Differences in DeBacker Score in children of different age categories(baseline)

Study Sites (1)

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