Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method

NCT ID: NCT05324228

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2022-09-16

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.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preschool children

10 preschool healthy children aged 3-5,9 years.

No interventions assigned to this group

Children of younger school age

10 children of younger school age aged 6-10,9 years.

No interventions assigned to this group

Children in puberty

10 children in puberty aged 11-14,9 years

No interventions assigned to this group

Postpubertal adolescents

10 postpubertal adolescents aged 15-18,9 years.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• healthy child
• informed consent of parents

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vlasta Krausová

OTHER

Sponsor Role: lead

Responsible Party

Vlasta Krausová

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Neumann, MD, Ph.D

Role: STUDY_CHAIR

University Hospital in Hradec Kralove

Locations

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Ústí nad Labem, , Czechia

Countries

Czechia

Other Identifiers

300/7

Identifier Type: -

Identifier Source: org_study_id