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Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05324228
Enrollment
40
Registered
2022-04-12
Start date
2021-12-03
Completion date
2022-09-16
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Microcirculation, Children

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.

Interventions

None listed

Sponsors

Vlasta Krausová
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy child * informed consent of parents

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of DeBacker Score of sublingual microcirculation of childrenbaselineIn 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 Total Vascular Density of sublingual microcirculation of childrenbaselineTotal length of vessels divided by total surface of area
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of childrenbaselineThe 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 childrenbaselineTotal 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 Proportion of Perfused Vessels (all) of sublingual microcirculation of childrenbaselineThe proportion of perfused vessels (PPV \[%\]) can be calculated as follows: 100 × (total number of vessels - \[no flow + intermittent flow\])/total number of vessels.
Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of childrenbaselineThe 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 childrenbaselineTotal length of vessels - (no flow + intermittent flow) divided by total surface of area
Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of childrenbaselineTotal 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).

Secondary

MeasureTime frameDescription
Differences in Total Vascular Density in children of different age categoriesbaselineTotal 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.
Differences in Microvascular Flow Index (MFI) in children of different age categoriesbaselineThe 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.
Differences in Small Vessel Density in children of different age categoriesbaselineTotal 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.
Differences in Proportion of Perfused Vessels (all) in children of different age categoriesbaselineThe 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.
Differences in Perfused Vessel Density (all) in children of different age categoriesbaselineTotal 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.
Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categoriesbaselineThe 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.
Differences in Perfused Small Vessel Density (PVD) in children of different age categoriesbaselineTotal 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.
Differences in DeBacker Score in children of different age categoriesbaselineIn 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026