Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-13 @ 5:17 PM
Study NCT ID:
NCT05324228
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2022-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method
Sponsor:
Vlasta Krausová
Organization:
Study Overview
Official Title:
Determination of Reference Values for Sublingual Microcirculation in Healthy Volunteers in the Pediatric Population Using the Sidestream Dark-Field Imaging Method
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: