HealthyNCT05324228
Sublingual Microcirculation in Healthy Children Using the SDF Imaging Method
An observational study of Healthy, run by Vlasta Krausová at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Dec 2021to 16 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- healthy child
- informed consent of parents
Who cannot join
- inability to cooperate
- acute illness
- chronic illness
- chronic medication
- substance abuse
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Ústí nad Labem
About this study
Official title: Determination of Reference Values for Sublingual Microcirculation in Healthy Volunteers in the Pediatric Population Using the Sidestream Dark-Field Imaging Method
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.
Read the 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
- Keywords
- Microcirculation, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preschool children | 10 preschool healthy children aged 3-5,9 years. | |
| Children of younger school age | 10 children of younger school age aged 6-10,9 years. | |
| Children in puberty | 10 children in puberty aged 11-14,9 years | |
| Postpubertal adolescents | 10 postpubertal adolescents aged 15-18,9 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Total Vascular Density of sublingual microcirculation of children
Total length of vessels divided by total surface of area
Measured: baseline
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children
The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Measured: baseline
Determination of Small Vessel Density of sublingual microcirculation of children
Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Measured: baseline
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children
The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels.
Measured: baseline
Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children
The proportion of perfused small vessels (PPV [%]) can be calculated as follows: 100 × (total number of small vessels - [no flow + intermittent flow])/total number of small vessels.
A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Measured: baseline
Determination of Perfused Vessel Density (all) of sublingual microcirculation of children
Total length of vessels - (no flow + intermittent flow) divided by total surface of area
Measured: baseline
Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of children
Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Measured: baseline
Determination of DeBacker Score of sublingual microcirculation of children
In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines.
Measured: baseline
Secondary outcomes (8)
Differences in Total Vascular Density in children of different age categories
Total length of vessels divided by total surface of area. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Microvascular Flow Index (MFI) in children of different age categories
The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules). Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Small Vessel Density in children of different age categories
Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Proportion of Perfused Vessels (all) in children of different age categories
The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Perfused Vessel Density (all) in children of different age categories
Total length of vessels - (no flow + intermittent flow) divided by total surface of area. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories
The proportion of perfused small vessels (PPV [%]) can be calculated as follows: 100 × (total number of small vessels - [no flow + intermittent flow])/total number of small vessels.
A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules). Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in Perfused Small Vessel Density (PVD) in children of different age categories
Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Differences in DeBacker Score in children of different age categories
In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines. Comparison in children aged 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start3 Dec 2021
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vlasta Krausová
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vlasta Krausová, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- David Neumann, MD, Ph.D, Study chair, University Hospital in Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324228
- Sponsor's protocol ID
- 300/7
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Reference Values for Sublingual Microcirculation in Healthy Volunteers in the Pediatric Population Using the Sidestream Dark-Field Imaging Method
- ClinicalTrials.gov ID
- NCT05324228
- Acronym / sponsor ID
- 300/7
- Conditions
- Healthy
- Keywords
- Microcirculation, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vlasta KrausováUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preschool children | – | –10 preschool healthy children aged 3-5,9 years. |
| Children of younger school age | – | –10 children of younger school age aged 6-10,9 years. |
| Children in puberty | – | –10 children in puberty aged 11-14,9 years |
| Postpubertal adolescents | – | –10 postpubertal adolescents aged 15-18,9 years. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- healthy child
- informed consent of parents
Key exclusion criteria (5 listed)
- inability to cooperate
- acute illness
- chronic illness
- chronic medication
- substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of Total Vascular Density of sublingual microcirculation of children
Time frame: baseline
Total length of vessels divided by total surface of area
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children
Time frame: baseline
The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Small Vessel Density of sublingual microcirculation of children
Time frame: baseline
Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children
Time frame: baseline
The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels.
Determination of Proportion of Perfused Small Vessels (PPV) of sublingual microcirculation of children
Time frame: baseline
The proportion of perfused small vessels (PPV [%]) can be calculated as follows: 100 × (total number of small vessels - [no flow + intermittent flow])/total number of small vessels. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of Perfused Vessel Density (all) of sublingual microcirculation of children
Time frame: baseline
Total length of vessels - (no flow + intermittent flow) divided by total surface of area
Determination of Perfused Small Vessel Density (PVD) of sublingual microcirculation of children
Time frame: baseline
Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).
Determination of DeBacker Score of sublingual microcirculation of children
Time frame: baseline
In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines.
8 secondary outcomes
Differences in Total Vascular Density in children of different age categories
Time frame: baseline
Differences in Microvascular Flow Index (MFI) in children of different age categories
Time frame: baseline
Differences in Small Vessel Density in children of different age categories
Time frame: baseline
Differences in Proportion of Perfused Vessels (all) in children of different age categories
Time frame: baseline
Differences in Perfused Vessel Density (all) in children of different age categories
Time frame: baseline
Differences in Proportion of Perfused Small Vessels (PPV) in children of different age categories
Time frame: baseline
Differences in Perfused Small Vessel Density (PVD) in children of different age categories
Time frame: baseline
Differences in DeBacker Score in children of different age categories
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Neumann, MD, Ph.D study chair
University Hospital in Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Vlasta Krausová at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Total Vascular Density of sublingual microcirculation of children (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.