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…
ID
Bron
Aandoening
Intensive care, EEG, neuromonitoring, coma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
Several 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.
Doel van het onderzoek
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).
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
N/A
Publiek
[default]
The Netherlands
+31 (0)43 3877272
v.kranen.mastenbroek@mumc.nl
Wetenschappelijk
[default]
The Netherlands
+31 (0)43 3877272
v.kranen.mastenbroek@mumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Severe skull injuries making EEG-electrode application impossible.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2207 |
| NTR-old | NTR2331 |
| CCMO | NL30161.068.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34917 |