To establish a healthy control group for microcirculatory parameters for current and future studies on the paediatric microcirculation.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Not applicable.
Background summary
The classic approach to evaluate circulatory failure is focused on the
macrocirculation (e.g. blood pressure and cardiac output). However, accurate
measurements of these parameters require techniques, which are invasive and
unreliable and therefore not preferable in children. Bedside monitoring of the
microcirculation with handheld video-microscopy cameras offers new ways for a
non-invasive approach for hemodynamic monitoring in critically ill children.
The microcirculation consists of all vessels smaller than 100 micrometres
(mostly arterioles, capillaries and venules) and is responsible for the actual
oxygen and nutrient exchange of cells and tissues. Implementing
microcirculatory targets could therefor aid in assuring optimal oxygen
delivery, as we have shown under a variety of conditions in new-borns and
children admitted to the intensive care. Despite its vital role, minimal
research has been done on the microcirculation in healthy children and research
in adults cannot be extrapolated. In order to study the pathophysiology of the
microcirculation, first, normal ranges of microcirculatory parameters in
healthy children have to be established.
Study objective
To establish a healthy control group for microcirculatory parameters for
current and future studies on the paediatric microcirculation.
Study design
A prospective observational cohort study in primary, secondary and high schools
in Rotterdam and at our level III children*s university hospital.
Study burden and risks
No risks are associated with participation and the burden of the study is
minimal. The used video microscopy technique offers the opportunity to
visualize and analyse the microcirculation in a non-invasive manner, proven by
studies in children of different age groups conducted in our institution in the
past. The device is gently positioned towards the sublingual mucosa and 5 video
clips of each 6 seconds are recorded. The procedure is short of duration, safe
and pain free, and the live videos can be seen by the children themselves.
Children until 7 years old will be measured after induction for their elective
surgery. Due to their young age measurements can only be performed in a sedated
state. Anaesthesia will be protocolized following current clinical practice.
Children from the age of 6 and up will be measured awake. The children and/or
parents will be asked to fill in a one-page questionnaire on the basic
information and medical history of the child. In order to study the
pathophysiology of the microcirculation, first, normal ranges of
microcirculatory variables in healthy children have to be established. This
data is currently not available and data from healthy adults is scarce and
cannot be extrapolated to children.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62060.078.17 |