To obtain intermittent buccal and continuous sublingual microcirculatory profiles by sidestream dark-field imaging before and after induction of propofol by non-invasive diagnostics in infants and children.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
circulatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to determine the effect of propofol on buccal and
sublingual microcirculation in children.
Both buccal and sublingual microcirculations will be evaluated with a CytoCam
an optical spectroscopic sensor-based digital video imaging instrument
(Braedius Medical BV, The Netherlands). The buccal capillary density will be
quantified by mean buccal capillary density and functional capillary density
(FCD). Sublingual microcirculation profile consists of blood vessel diameter
(BVd), proportion of perfused vessels (PVV), perfused vessel density (PVD),
microcirculatory flow index (MFI) and total vascular density (TVD).
Macrocirculation will be monitored by blood pressure and heart rate and
hemoglobin oxygen saturation by pulse oximetry.
Secondary outcome
not applicable
Background summary
Propofol is the first choice sedative agent used for procedural sedation.
Propofol has significant hemodynamic effects. It decreases vascular tone and
reduces venous return, which is reflected by significant hypotension. Arterial
hypotension associated with the induction and infusion of propofol is mainly a
result of a decrease in afterload without compensatory increases in heart rate
or cardiac output (Claeys et al. Br J Anaesth 1988;60:3-9). However, evaluation
of macrocirculation by measuring blood pressure does not reflect
microcirculation.
Only two studies have been performed in adult humans using non-invasive
radiological imaging techniques to study the effect of propofol on
microcirculation. No studies have been performed in infants and children.
Study objective
To obtain intermittent buccal and continuous sublingual microcirculatory
profiles by sidestream dark-field imaging before and after induction of
propofol by non-invasive diagnostics in infants and children.
Study design
Single center, prospective, observational study.
Study burden and risks
Subjects will have no direct benefits of participating in this study. Due to
the observational character of this study, the risks are minimal. We aim to
assess the above presented objectives using a video microscope system
(CytoCam), which is a non-invasive techniques. No adverse events have been
reported using this instrument. The only possible burden could be that some
minor manipulation of the camera in the mouth of the child may be required to
obtain qualitatively good images. No blood samples will be obtained.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
-procedural sedation with propofol
-children 8-18 years
Exclusion criteria
no written informed consent
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 | NL51821.018.14 |