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Completed

NCT Number: NCT05324228

Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

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.

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Key information

Conditions

Healthy

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Ústí nad Labem, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy child
  • informed consent of parents

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Determination of Total Vascular Density of sublingual microcirculation of children

    Time frame: baseline

    Total length of vessels divided by total surface of area

  2. 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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

  7. 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).

  8. 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.

Secondary outcomes

  1. Differences in Total Vascular Density in children of different age categories

    Time frame: baseline

    Total length of vessels divided by total surface of area. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  2. Differences in Microvascular Flow Index (MFI) in children of different age categories

    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). Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  3. Differences in Small Vessel Density in children of different age categories

    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).Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  4. Differences in Proportion of Perfused Vessels (all) in children of different age categories

    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. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  5. Differences in Perfused Vessel Density (all) in children of different age categories

    Time frame: baseline

    Total length of vessels - (no flow + intermittent flow) divided by total surface of area. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  6. Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories

    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). Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  7. Differences in Perfused Small Vessel Density (PVD) in children of different age categories

    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).Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

  8. Differences in DeBacker Score in children of different age categories

    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. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.

Sponsors and collaborators

Lead sponsor

Vlasta Krausová

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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