Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

Study 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.

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

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy child informed consent of parents Exclusion Criteria: inability to cooperate acute illness chronic illness chronic medication substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preschool children<br>10 preschool healthy children aged 3-5,9 years. | |
| Children of younger school age<br>10 children of younger school age aged 6-10,9 years. | |
| Children in puberty<br>10 children in puberty aged 11-14,9 years | |
| Postpubertal adolescents<br>10 postpubertal adolescents aged 15-18,9 years. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Total Vascular Density of sublingual microcirculation of children | Total length of vessels divided by total surface of area | baseline | 
| Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children | 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). | baseline | 
| Determination of Small Vessel Density of sublingual microcirculation of children | 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). | baseline | 
| Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children | The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels. | baseline | 
| Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children | 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). | baseline | 
| Determination of Perfused Vessel Density (all) of sublingual microcirculation of children | Total length of vessels - (no flow + intermittent flow) divided by total surface of area | baseline | 
| Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of children | 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). | baseline | 
| Determination of DeBacker Score of sublingual microcirculation of children | 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. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Total Vascular Density in children of different age categories | 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. | baseline | 
| Differences in Microvascular Flow Index (MFI) in children of different age categories | 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. | baseline | 
| Differences in Small Vessel Density in children of different age categories | 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. | baseline | 
| Differences in Proportion of Perfused Vessels (all) in children of different age categories | 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. | baseline | 
| Differences in Perfused Vessel Density (all) in children of different age categories | 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. | baseline | 
| Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories | 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. | baseline | 
| Differences in Perfused Small Vessel Density (PVD) in children of different age categories | 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. | baseline | 
| Differences in DeBacker Score in children of different age categories | 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. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microcirculation, Children