Acute Neurological Insult
Conditions
Brief summary
After any acute brain injury, a primary pathophysiological response arises, enabling the brain to develop seizures and/or a status epilepticus (SE). These are frequently reported in patients admitted to the intensive care unit (ICU) with traumatic brain injury and brain injury caused by subarachnoid or intracerebral hemorrhage. Seizures can be presented without any clinical motor signs, which are then termed as nonconvulsive, and therefore remain frequently clinically unrecognized. As such, it is of great importance that these patients are diagnosed as early as possible since the increased metabolic demand and blood flow associated with an epileptic insult may further compromise the brain at risk. Thus far, continuous EEG (cEEG) is the only clinical instrument that is able to detect the development of early epileptic activity. Unfortunately, cEEG is not available in most ICUs and is labor-intensive, expensive and difficult to interpret for non-trained physicians. Therefore, a more simple and prognostic accurate EEG device is highly warranted to detect seizures in an early stage so that patients might benefit from a specific and early treatment. A validation study in comatose patients with an acute neurological insult will be conducted to provide evidence that simplified Bispectral Index EEG monitoring has the potential to detect epileptic activity as reliable as its gold standard, full EEG monitoring. Thereby, BIS EEG monitoring could possibly be used to facilitate the prognostication and management of epileptic seizures in this patient cohort which could eventually improve the clinical outcome.
Interventions
DEVICEBispectral index (BIS) EEG monitoring
The Bispectral Index (BIS) EEG monitor is a simplified EEG monitoring device which was originally designed to monitor the depth of hypnosis during general anesthesia. It does this by analyzing changes in the processed electroencephalogram (EEG) which occur with the hypnotic state and creating a measure (or index) indicative of these changes. A number between 0 and 100 is derived, with values above 70 associated with an awake state. The monitor also provides a single channel EEG, an electromyogram (EMG) and an index of signal quality (SQI), all in real time.
Sponsors
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (age ≥ 18 years) admitted to the ICU with an acute neurological insult which will be sedated/ventilated (Glasgow Coma Scale (GCS) ≤ 8). * Ability to place BIS sensors on the forehead * Written informed consent form has to be obtained from the patient's next of kin and has to be reconfirmed if the patient regains consciousness
Exclusion criteria
* Age \< 18 years * Inability to place BIS sensors on the forehead (e.g. due to frontal decompression)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A comparison between BIS derived EEG and standard full EEG | 15 minutes before or after the acquisition of standard full EEG monitoring. | Unfiltered BIS derived EEG data from 15 minutes before or after the acquisition of a full intermittent EEG will be used to compare BIS derived EEG traces with full intermittent EEG traces. These data will be (retrospectively) analyzed by experienced neurophysiologists for the presence of seizures and/or status epilepticus. |
Countries
Belgium
Contacts
Primary ContactWard Eertmans, drs.
Backup ContactFrank Jans, prof. dr.
Outcome results
None listed