Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324228
• Other study ID #: 300/7
• Status: Completed
• Start date: December 3, 2021
• Est. completion date: September 16, 2022

Study information

• Verified date: April 2023
• Source: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• healthy child

• informed consent of parents

Exclusion Criteria:

• inability to cooperate

• acute illness

• chronic illness

• chronic medication

• substance abuse

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Czechia	Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.	Ústí Nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Vlasta Krausová

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of Total Vascular Density of sublingual microcirculation of children	Total length of vessels divided by total surface of area	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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