Continuous neuromonitoring in critically ill patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27058

Enrollment

150

Registered

2010-05-25

Start date

2010-06-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive care, EEG, neuromonitoring, coma

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older; 2. Glasgow coma scale < 9; 3. Admitted to the ICU; 4. 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

Exclusion criteria: Severe skull injuries making EEG-electrode application impossible.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the sensitivity and specificity of the developed monitoring tool for detection of secondary events (seizures, focal cerebral ischemia) as compared to the gold standard (evaluation of the EEG by a clinical neurophysiologist).	—

Secondary

Measure	Time frame
Secondary objectives are mainly observation of clinical data and events which are useful for the future implementation of the developed monitoring device. Topics to be described and questions to be answered are (amongst others): 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?	—

Measure

Time frame

Secondary objectives are mainly observation of clinical data and events which are useful for the future implementation of the developed monitoring device. Topics to be described and questions to be answered are (amongst others): 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?

—

Contacts

Public ContactV.H.J.M. Kranen-Mastenbroek, van

v.kranen.mastenbroek@mumc.nl+31 (0)43 3877272

Outcome results