EEG Monitoring for Refractory Status Epilepticus
The Use of Continuous Electroencephalographic (EEG) Monitoring for Cases of Refractory Status Epilepticus: Does it Affect the Final Patient Outcome
Barts & The London NHS Trust
40 participants
Mar 17, 2020
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria8
- Patients aged > 16 years
- Consent obtained according to Mental Capacity Act 2005
- Patients admitted to ICU for treatment of status epilepticus or admitted for another reason and diagnosed with SE during their admission
- Convulsive Status epilepticus defined by either:
- Tonic-clonic SE lasting longer than 5 minutes,
- Focal SE with impaired consciousness lasting longer than 10 minutes
- or Non-Convulsive SE according to Salzburg consensus criteria
- Status epilepticus that continues despite treatment with benzodiazepine and one antiepileptic medication
Exclusion Criteria1
- Anoxic brain injury
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04170491