Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

V

Vlasta Krausová

Status

Completed

Conditions

Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT05324228
300/7

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

3 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy child
  • informed consent of parents

Exclusion criteria

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

Trial design

40 participants in 4 patient groups

Preschool children
Description:
10 preschool healthy children aged 3-5,9 years.
Children of younger school age
Description:
10 children of younger school age aged 6-10,9 years.
Children in puberty
Description:
10 children in puberty aged 11-14,9 years
Postpubertal adolescents
Description:
10 postpubertal adolescents aged 15-18,9 years.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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