An observational study on the microcirculation in healthy children

An observational study on the microcirculation in healthy children - HuMBLE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44428

Enrollment

Registered

2018-01-16

Start date

2018-03-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not applicable

Interventions

children

hemodynamic monitoring

microcirculation

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: For group (A): - Healthy children from the age of 0 until 7 years old; - Undergoing non-cardiac elective surgery; - Mechanical ventilation through an endotracheal tube; - Parental informed consent. ;For group (B): - Healthy children from the age of 6 until 18 years old; - Informed consent: o Parental informed consent for all children from the age of 6 until 16 years old; o Informed co-consent of children from the age of 12 until 16 years old; o Informed consent of children from the age of 16 until 18 years old.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: For group (A): - Absence of parental informed consent; - Preterm new born (adjusted age * 36 weeks); - Cardiovascular, renal or oncological disease; - Mechanical or spontaneous ventilation through a larynx mask airway.;For group (B): - Absence of (parental) informed consent; - Cardiovascular, renal or oncological disease; - Use of drugs; - Smoking; - Pregnancy.

Design outcomes

Primary

Measure	Time frame
With incident dark field illumination (IDF) imaging, a video-microscopy technique that allows the direct visualization of the sublingual microcirculation, variables of vessel density (total vessel density (TVD) and perfused vessel density (PVD)), two indexes of vascular perfusion (microvascular flow index (MFI) and proportion of perfused vessels (PPV)) and a heterogeneity index of the flow (heterogeneity index (HI)) will be collected. Demographic data and medical history will also be assessed before measurements.	—

Measure

Time frame

With incident dark field illumination (IDF) imaging, a video-microscopy technique that allows the direct visualization of the sublingual microcirculation, variables of vessel density (total vessel density (TVD) and perfused vessel density (PVD)), two indexes of vascular perfusion (microvascular flow index (MFI) and proportion of perfused vessels (PPV)) and a heterogeneity index of the flow (heterogeneity index (HI)) will be collected. Demographic data and medical history will also be assessed before measurements.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)