Clinical trial NCT05324228: Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method
Official title: Determination of Reference Values for Sublingual Microcirculation in Healthy Volunteers in the Pediatric Population Using the Sidestream Dark-Field Imaging Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Microcirculation
Children
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* healthy child
* informed consent of parents

Exclusion Criteria:

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

Primary outcomes:
measure: Determination of Total Vascular Density of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Small Vessel Density of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Perfused Vessel Density (all) of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of children
timeFrame: baseline
measure: Determination of DeBacker Score of sublingual microcirculation of children
timeFrame: baseline
Secondary outcomes:
measure: Differences in Total Vascular Density in children of different age categories
timeFrame: baseline
measure: Differences in Microvascular Flow Index (MFI) in children of different age categories
timeFrame: baseline
measure: Differences in Small Vessel Density in children of different age categories
timeFrame: baseline
measure: Differences in Proportion of Perfused Vessels (all) in children of different age categories
timeFrame: baseline
measure: Differences in Perfused Vessel Density (all) in children of different age categories
timeFrame: baseline
measure: Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories
timeFrame: baseline
measure: Differences in Perfused Small Vessel Density (PVD) in children of different age categories
timeFrame: baseline
measure: Differences in DeBacker Score in children of different age categories
timeFrame: baseline
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Study officials:
affiliation: University Hospital in Hradec Kralove
name: David Neumann, MD, Ph.D
role: STUDY_CHAIR
References: