We aim to study the patient specific threshold for arterial blood pressure to maintain adequate cerebral perfusion (CBFV) in the perioperative setting and the association between perioperative abnormalities with postoperative brain damage and…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint is the Critical Closing Pressure (CrCP) within and between
subjects.
Detection of the critical closing pressure (CrCP) of the brain, the arterial
blood pressure at which brain vessels collapse and cerebral blood flow ceases,
in a cohort of neonates who need major cardiac and non-cardiac surgery. We
hypothesize that neonates have a unique CrCP and cerebral ischemia occurs
during episodes with critically endangered blood supply to the brain, when the
arterial blood pressure (iABP) is below CrCP.
Secondary outcome
- Lower Limit of Autoregulation (LLA)
- Intraoperative blood pressure variation
- Mean CrCP difference between neonates with absent and new WMI on the
postoperative MRI
- Description and number of cerebral hypoperfusion events (iABP < CrCP) per
unit of time.
- Number of events with reversed cerebral flow (resistive index > 1) per unit
of time.
- Gaseous microemboli (GME) volumes and counts
- Description of venous CBF patterns and incidence of abnormal cerebral venous
return.
- Detection of postoperative hyperperfusion
Background summary
During cardiac surgery, neonates are at high risk of cerebral damage: 36-78%
will have new cerebral lesions after surgery. In the neonates after non-cardiac
surgery the incidence of new white matter injury is up to 58%. Adequate
cerebral perfusion (CBF) is mandatory to prevent postoperative brain damage and
neurobehavioral outcomes. For CBF, the systemic blood pressure should be
managed above the brain*s critical closing pressure (CrCP), and preferably
above the lower limit of autoregulation (LLA), if intact.
Study objective
We aim to study the patient specific threshold for arterial blood pressure to
maintain adequate cerebral perfusion (CBFV) in the perioperative setting and
the association between perioperative abnormalities with postoperative brain
damage and neurobehavioral outcomes.
Study design
In a prospective observational cohort study bilateral cerebral blood flow
velocity (CBFV) measurements are performed with transcranial doppler (TCD),
together with invasive arterial blood pressure (iABP) measurements in the
perioperative period.
Study burden and risks
Anticipated risks caused by TCD monitoring in neonates are considered
negligible when monitoring is executed according to the BMUS guidelines and
ALARA principle. Each time energy is converted from one form to another, part
of it is inevitably converted to heat. Theoretically, if at all, the maximum
temperature rise will happen at the skin- temporal bone side, where the
monitoring probes are placed. A maximal thermal index (TI) of 0.7 is allowed,
this corresponds with 0.7 degrees C temperature rise.
Patients might not benefit from participation in this study as the TCD
measurements are only visible and available to the TCD operator, and we do not
yet know how the results could possibly influence the procedure. However, in
the unlikely situation where cerebral perfusion is severely compromised for a
longer period of time or in case of occurrence of large air emboli, improper
cannulation or cross clamping the cardiac team will be notified. Therefore, a
neonate may benefit from participation.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Term infant aged < 42 days / Preterm born > 32 weeks and with a corrected age
< 42 days
- (Semi-) elective cardiac surgery
- Routine placement of an arterial cannula for invasive blood pressure
monitoring.
Exclusion criteria
- Grade III-IV intracranial hemorrhage.
- Emergency surgery or semi-elective surgery performed out of hours.
- Informed consent from the parents is not obtained.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT04713605 |
| CCMO | NL76532.041.21 |