EEG Monitoring for Refractory Status Epilepticus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorBarts & The London NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Tonic-clonic SE lasting longer than 5 minutes,

Disqualifiers

Anoxic brain injury

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: controlNo intervention 0 interventions
Group B: cEEGExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Length of ICU stay

The length of ICU stay will be measured as the primary outcome measure. This will be compared between the two groups.

Time frame
18 months from recruitment onset (anticipated)

Secondary outcomes

1

Health status evaluation

Assessed with EQ-5D-5L scale. Maximum value 1 indicates reported full health state. Minimum value -0.594.

Time frame
End of the study- 3 years
2

Mortality

In-hospital and/or 30-days mortality

Time frame
18 months from recruitment onset
3

Hospital charges

The hospital charges (in British pounds) will be compared between the two groups.

Time frame
End of the study- 3 years

Other outcomes

Sponsors and contacts

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