EEG Monitoring for Refractory Status Epilepticus
Sponsor: Barts & The London NHS Trust • ClinicalTrials.gov ID: NCT04170491
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This is a prospective randomized study to investigate the yield of continuous electroencephalogram (cEEG), as a diagnostic tool in intensive care unit (ICU), for patients with refractory status epilepticus (RSE) and the contribution of this test to the patient final outcome, compared with standard medical care. Specifically, the hypothesis is that the use of cEEG for patients with RSE will significantly reduce the length of in-hospital stay, mortality, and subsequent complications (such as infections or pressure ulcers). It is also predicted that quality of life will be higher following cEEG at 0, 3, 6 and 12 months after discharge. As there are currently no data available from previous studies assessing the impact of cEEG on markers of the final clinical outcome in patients with RSE, this study is going to start as a feasibility study, aiming to obtain initial data for the primary outcome measure, in order to perform a sample size calculation for a larger future trial. The pilot study will also assess the integrity of the study protocol, specifically the recruitment process and the consent procedure, and also determine the necessary costs for running a cEEG service in ICU for patients with RSE
Interventions
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Continuous EEG
(Diagnostic test)
Continuous EEGs will be performed with 21 electrodes and polygraphy (ECG and EMG) placed according to the international 10-20 system. In case of extensive neurosurgical defects, a reduced montage may be applied in patients from either group. This information will be added in CRF. The reduced montage in these cases is not expected to reduce the diagnostic accuracy and the outcome, as the neurophysiological changes are generally diffuse and will be detected by adjacent electrodes.
Eligibility criteria
Conditions
Locations
- Royal London Hospital — London, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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