To gain understanding about the changes in intracranial hemodynamics in severe head injury. To improve the early detection of an autoregulation syndrome.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurement of PaR value for the right and left middle cerebral artery on day
0-5 after admission in relation to the mean arterial blood pressure and the
end-tidal carbon dioxide.
Secondary outcome
not applicable
Background summary
In the first few days after traumatic brain injury an increased risk for the
development of secondary changes due to cerebral oedema and haemorrhage is
present. To provide an optimal cerebral perfusion, the regulation of the blood
pressure is one of the main goals during the first days after admission. All
patients are admitted to the ICU and an intracranial pressure (ICP) device is
inserted to measure the intracranial pressure. With the ICP in combination with
the blood pressure (ABP) the cerebral perfusion pressure is calculated.
Treatment of the patient is guided by changes in ICP and CPP. The property of
the cerebral arteries to adjust to changes in blood pressure to provide an
optimal cerebral blood flow is called the cerebral autoregulation. Some
patients with ICP-monitoring develop disturbed autoregulation with subsequent
increase of ICP with oedema and risk of cerebral herniation.
In the present investigation the management protocol is expanded by a
simultaneous recording of bilateral TCD signals combined with the end-tidal
carbon dioxide and the arterial blood pressure. All additional signals are
recorded non-invasively. The recording of these extra signals will allow the
calculation of a so-called PaR-value, which hypothetically provides better
information on intracranial hemodynamics than ICP alone
Firstly, this study is a feasability study (can all non-invasive data be
acquired succesfully?), secondly it is a pilot observational study (can values
for the PaR parameter be related to changes in the patients clinical
condition?).
Study objective
To gain understanding about the changes in intracranial hemodynamics in severe
head injury. To improve the early detection of an autoregulation syndrome.
Study design
Instead of the usual monitoring of cerebral perfusion pressure with
ICP-monitoring, the study is designed to record simultaneously with the ICP
bilateral TCD signals combined with the end-tidal carbon dioxide and the
arterial blood pressure. All signals are recorded non-invasively. Combining the
TCD signal with the ABP signal will allow the calculation of the so-called
pulsatile apparent resistance or PaR, a parameter that has been shown to
provide better information on intracranial hemodynamics than ICP and or TCD
alone.
Study burden and risks
The subjects will undergo daily PaR-measurement during the first 5 days after
admission. The usual TCD examination takes about 30 minutes, whereas the PaR
measurement takes roughly 60 minutes (30 min. preparation; 30 min. actual
measurement).
As the PaR-measurements all are non-invasive and are done in patients who are
sedated for ICP-monitoring no significant burden or risk for the patient is
present.
PO Box 30.001
9700 RB Groningen
Nederland
PO Box 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Glasgow Coma Scale <=8
- age > 17 years
Exclusion criteria
age < 18 years; carotid occlusion or severe stenosis in history
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 | NL17614.042.07 |