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Continuous neuromonitoring in critically ill patients.


- candidate number8077
- NTR NumberNTR2331
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mei-2010
- Secondary IDsNL30161.068.09 / MEC 09-2-116 CCMO / MUMC
- Public TitleContinuous neuromonitoring in critically ill patients.
- Scientific TitleContinuous neuromonitoring in critically ill patients.
- ACRONYM
- hypothesisThe 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).
- Healt Condition(s) or Problem(s) studiedIntensive care, Electroencephalography (EEG), Coma, Neuromonitoring
- Inclusion criteria1. 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 criteriaSevere skull injuries making EEG-electrode application impossible.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jun-2010
- planned closingdate1-jun-2014
- Target number of participants150
- InterventionsN/A
- Primary outcomeThe 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 outcomeSecondary 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?
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. V.H.J.M. Kranen-Mastenbroek, van
- CONTACT for SCIENTIFIC QUERIESDrs. D.M.W. Hilkman
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summarySeveral neurological disorders are not clinically detectable in critically ill patients. 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. Neither continuous neuromonitoring of this population, nor therapeutic interventions on this basis are however part of contemporary routine practice.

Objective: The primary objective of this study is to develop and implement the use of an EEG-tool to monitor brain function in all adult patients at risk for deterioration of brain function, development of (non)convulsive seizures or cerebral ischemia. The tool should be reliable, easy to use by ICU personnel and allow remote monitoring by the clinical neurophysiologist.
- Main changes (audit trail)
- RECORD25-mei-2010 - 28-mei-2010


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