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

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Czechia
  • Ústí Nad Labem, Czechia
    • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 14 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will include 40 healthy volunteers. Of these, 10 pre-school children (3-5.9 years), 10 younger school children (6-10.9 years), 10 children in puberty(11-14.9 years) and 10 post-puberty adolescents will be included (15-18.9 years).

Description

Inclusion Criteria:

• healthy child
• informed consent of parents

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Preschool children; 10 preschool healthy children aged 3-5,9 years.
Children of younger school age; 10 children of younger school age aged 6-10,9 years.
Children in puberty; 10 children in puberty aged 11-14,9 years
Postpubertal adolescents; 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

Collaborators and Investigators

• Sponsor: Vlasta Krausová
• Investigators: Study Chair: David Neumann, MD, Ph.D, University Hospital in Hradec Kralove

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Children; Microcirculation
• Other Study ID Numbers: 300/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No