Primarily, to assess the effect of changing CO2 levels on the sublingual microcirculation, cerebral oxygenation, and cerebral perfusion. Secondarily, to assess if and how sublingual microcirculatory parameters, parameters of cerebral oxygenation,…
ID
Source
Brief title
Condition
- Gastrointestinal tract disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- End tidal CO2 (etCO2, kPa);
- Transcutaneous partial pressure CO2 (PCCO2, kPa);
- Sublingual microcirculation: parameters of vessel density (total vessel
density (TVD, mm/mm2) and perfused vessel density (PVD, mm/mm2)) and parameters
of vascular perfusion (microvascular flow index (MFI), proportion of perfused
vessels (PPV, %), red blood cell velocities (RBCV, mm/s) and heterogeneity
index of flow (heterogeneity index (HI)));
- Cerebral oxygenation: regional cerebral oxygen saturation (rScO2, %);
- Cerebral perfusion: cerebral blood flow velocities (CBFV, cm/s) of the
lateral striate artery and the medial cerebral artery;
- Cerebral activity: neuronal electrical activity and background patterns over
time.
Secondary outcome
Not applicable
Background summary
Carbon dioxide (CO2) is the primary insufflation gas used for pneumoperitoneum
during laparoscopy and yields systemic and regional hemodynamic alterations.
The effects of these alterations on local and cerebral tissue oxygenation have
not yet been fully understood, especially in infants.
Study objective
Primarily, to assess the effect of changing CO2 levels on the sublingual
microcirculation, cerebral oxygenation, and cerebral perfusion. Secondarily, to
assess if and how sublingual microcirculatory parameters, parameters of
cerebral oxygenation, and parameters of cerebral perfusion are correlated.
Study design
A single center observational prospective study.
Study burden and risks
No risks are associated with participation and the extend of the burden is
limited. Handheld vital microscope (HVM), Near Infrared Spectroscopy (NIRS),
Doppler Cranial Ultrasonography (Doppler CUS), and Amplitude Integrated
Electroencephalogram (aEEG) offer the opportunity to assess the sublingual
microcirculation, cerebral oxygenation, cerebral blood flow and cerebral
activity in a non-invasive manner, proven by studies in children of different
age groups conducted in our institution in the past and by the integration of
NIRS and aEEG in standard clinical care. The HVM is gently positioned on the
sublingual mucosa and 5 video clips of each 6 seconds are recorded. Due to
their young age measurements can only be performed in a sedated state. NIRS is
applied through transcutaneous sensors placed on the forehead, without being
harmful to the tissue or causing discomfort to the patient. The Doppler CUS
probe is gently positioned on the anterior fontanelle to allow direct
visualization of intracranial vessels. The aEEG is applied with the aid of
adhesive sensors placed on the head, which have no reported side effects. All
procedures are safe and pain-free and will not interfere with surgical and
anesthetic procedures. This study will help us better understand the effects of
CO2 pneumoperitoneum on local and cerebral tissue oxygenation in infants,
especially as their brain is still developing.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Cardiovascular healthy children 0 to 1 year of age undergoing laparoscopic
surgery
Exclusion criteria
- Absence or refusal of parental informed consent;
- Preterm new born (adjusted age * 36 weeks);
- Cardiovascular, pulmonary, renal, oncological disease;
- Genetic syndrome
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 | NL70270.078.19 |