The primary objective of this study is to develop reliable signal analyzing methods for the monitoring of brain function in adult patients at risk for deterioration of brain function, (non)convulsive seizures or cerebral ischemia. The methods will…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the sensitivity and specificity of the
developed monitoring system for detection of secondary events (seizures, focal
cerebral ischemia) as compared to the gold standard (evaluation of the EEG by a
clinical neurophysiologist).
Secondary outcome
An important secundairy endpoint will be the feasibility of cEEG.
Other secondary studypparameters are mainly observational and are useful for
future implementation of the developed monitoring system:
1. The prevalence of nonconvulsive seizures in critically ill patients.
2. What patients groups are most at risk for developing seizures?
3. Does the information gained by cEEG measurement have impact on clinical
patient management, for instance on therapeutic decision making?
4. Is it possible to detect the development of cerebral ischemia by continuous
EEG monitoring before clinical symptoms occur?
5. Is brain function, as measured by cEEG monitoring, influenced by general
health events such as hypotension, bradycardia and decrease of oxygen
saturation?
Background summary
Although monitoring of vital functions such as electrocardiogram (ECG), oxygen
saturation (pO2), pulse, bloodpressure and sometimes even brain tissue
pressure, is part of routine medical care in intensive care units, monitoring
of brain function by use of continous EEG (cEEG) registration is still in its
infancy. Critically ill patients, especially when comatose, are at risk for the
development of convulsive or nonconvulsive seizures. There is continuously
growing evidence that seizures and status epilepticus, convulsive or
non-convulsive, can harm the already vulnerable brain and thus negatively
influence prognosis.
Our hypothesis is that several neurological disorders, such as non convulsive
seizures and cerebral ischemia, are not clinically detectable in critically
ill patients , but that continuous monitoring of brain function can reveal some
of these disorders. Discovery of these events could potentially lead to
therapeutic interventions to prevent further damage to the brain and thereby
improve outcome.
Study objective
The primary objective of this study is to develop reliable signal analyzing
methods for the monitoring of brain function in adult patients at risk for
deterioration of brain function, (non)convulsive seizures or cerebral
ischemia. The methods will be implemented in a recording system thereby leading
to a monitoring tool that is reliable, easy to use by ICU personnel and allows
remote monitoring by the clinical neurophysiologist The primary objective of
this study is to develop reliable signal analyzing methods for the monitoring
of brain function in adult patients at risk for deterioration of brain
function, (non)convulsive seizures or cerebral ischemia. The methods will be
implemented in a recording system thereby leading to a monitoring tool that is
reliable, easy to use by ICU personnel and allows remote monitoring by the
clinical neurophysiologist
Study design
the study will be an observational study
Study burden and risks
As the patient is comatose, and the investigations used (EEG and TCD) are
completely non-invasive and not painfull, the study has a very low burden for
the patient. Except for a small risk on skin damage below the EEG-electrodes,
there is no risk for the patient.
postbus 5800
6202 AZ Maastricht
NL
postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older
glasgow coma scale < 9 and admitted to the ICU
One of the following conditions: intracerebral hemorrhage; subarachnoid hemorrhage; ischemic stroke; severe traumatic brain injury; (meningo)encephalitis; post-anoxic encephalopathy; intracranial surgery; (non)convulsive status epilepticus; cardiac arrest or ventricular fibrillation with cardial resuscitation
Exclusion criteria
Severe skull injuries making EEG-electrode application impossible
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL30161.068.09 |
| OMON | NL-OMON27058 |