Clinical Trials Directory

Trials / Completed

CompletedNCT05324228

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Vlasta Krausová · Academic / Other
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2021-12-03
Primary completion
2022-09-16
Completion
2022-09-16
First posted
2022-04-12
Last updated
2023-04-13

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT05324228. Inclusion in this directory is not an endorsement.