The Use of Continuous Electroencephalographic (EEG) Monitoring for Cases of Refractory Status Epilepticus: Does it Affect the Final Patient Outcome

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
United Kingdom
Royal London Hospital
RECRUITING
London
Contact Information
Primary
Vasiliki Tsirka, Consutlant
vasiliki.tsirka@nhs.net
00447407781374
Time Frame
Start Date: 2020-03-17
Estimated Completion Date: 2027-01
Participants
Target number of participants: 40
Treatments
No_intervention: control
The standard medical care (Control) group will receive sequential portable EEGs, performed according to clinical demand. These patients usually have 2 recordings of 20-30 minutes each within 24 or 48 hours. The studies include baseline recoding and recording after auditory, tactile and nociceptive stimulation. The EEGs will be visually reviewed and reported within 4 hours after the recording completion by a Consultant Clinical Neurophysiologist or other doctor with equivalent qualifications.
Experimental: cEEG
The treatment (cEEG) group will have cEEG applied within 12 hours of RSE diagnosis, which will continue until 24 hours after cessation of clinical and electrical seizure activity. Reactivity testing with auditory, tactile and nociceptive stimulation will be repeated at least once daily. The cEEG will be visually interpreted twice daily by a Consultant Clinical Neurophysiologist and the results will be communicated within two hours of their completion to the treating clinical team.
Related Therapeutic Areas
Sponsors
Leads: Barts & The London NHS Trust

This content was sourced from clinicaltrials.gov