NCT02545816

Comparing Simplified EEG Monitoring Tool With Standard EEG Monitoring in Patients With Acute Neurological Insult

A Validation Study to Compare Bispectral Index EEG Monitoring With Full EEG in Patients With an Acute Neurological Insult

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Neurological Insult

Interventions

Type	Name	Description
DEVICE	Bispectral 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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-09-10
• Last updated: 2018-03-27

Locations

1 site across 1 country: Belgium