An interventional study of continuous EEG (cEEG) and routine EEG (rEEG) in EEG With Periodic Abnormalities, EEG With Abnormally Slow Frequencies and Coma, sponsored by Andrea Rossetti, MD. Completed at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-25.
Sponsored by Andrea Rossetti, MD · Not applicable, Interventional, and Diagnostic
Continuous video-EEG monitoring (cEEG) significantly improves seizure or status epilepticus detection in patients in intensive care units (ICUs), and is recommended for patients with consciousness impairment. cEEG is time- and resource consuming as compared to routine EEG (rEEG, lasting 20-30 minutes). While centers in North America have been using it increasingly, most European hospitals still do not have resources to comply with these guidelines. In addition, only one population-based study based on discharge diagnoses suggested that cEEG may improve patients' outcome. Current guidelines are thus based upon weak evidence and expert opinions.
Aim of the study is to assess if cEEG in adults with consciousness impairment is related to an improvement of functional outcome, and to address the prognostic role of quantitative network EEG analyses.
In this multicenter randomized controlled trial, adults with GCS inferior or equal to 11 or FOUR score inferior or equal to 12 will be randomized 1:1 to cEEG for 30-48 hours or two rEEG within 48 hours. The primary outcome will be mortality at 6 months. Secondary outcomes will blindly assess functional outcome, seizure/status epilepticus detection rate, duration of ICU stay, change in patient management (antiepileptic drug introduced, increased, or stopped, brain imaging), and reimbursement. Additionally, quantitative EEG will be assessed towards the primary outcome. 350 patients are planned to be included.
Background: Continuous video-EEG monitoring (cEEG) is a non-invasive tool to monitor the electrical brain function; it significantly improves seizure or status epilepticus detection in comatose patients in intensive care units (ICUs), which often do not show any specific clinical correlates. Recently, the European Society of Intensive Care Medicine published guidelines regarding the use of cEEG in the ICUs, recommending it for most patients with consciousness disorders. cEEG is time- and resource consuming as compared to routine spot EEG (rEEG, typically lasting 20-30 minutes). While centers in North America have been using it increasingly, most European - and all Swiss - hospitals still do not have enough resources to comply with these guidelines. In addition, while the superiority of cEEG to detect non-convulsive seizures or status epilepticus is proven, only one population-based study based on discharge diagnoses suggested that cEEG may improve patients' outcome. Current guidelines are thus based upon weak evidence and expert opinions. If cEEG leads to improved patients' care remains elusive. Moreover, little attention has been drawn towards quantitative EEG information beyond visual analysis, and the impact of such information on diagnosis, treatment, and outcome remains unclear.
Aim: To assess whether the use of cEEG in patients with consciousness impairment is related to an improvement of functional outcome, and to address the prognostic role of quantitative network EEG analyses in this cohort. Also, a cost analysis will be performed.
Methods: In this multicenter randomized controlled trial, adults with a Glasgow Coma Score (GCS) inferior or equal to 11 or a FOUR score inferior or equal to 12, regardless of etiologies, will be randomized 1:1 to cEEG for 30-48 hours or two rEEG within 48 hours, interpreted in a standardized way. Patients with detected seizures in the last 36h or status epilepticus in the last 96h will be excluded, as cEEG may represent the standard of care. Demographics, etiology, Charlson Comorbidity Index, GCS, diagnosis leading to EEG, mechanical ventilation, and subsequent use of rEEG/cEEG will be collected. The primary outcome will be mortality at 6 months. Secondary outcomes will blindly assess functional outcome at 4 weeks and 6 months, as well as seizure/status epilepticus detection rate and time to detection, infections rate, duration of ICU stay, change in patient management (antiepileptic drug introduced, increased, or stopped, brain imaging), and reimbursement. Analyses will compare the two interventional groups (intention to diagnose) regarding outcome, as a whole and stratified according to etiological subgroups, and other variables of interest. Additionally, lope cross correlation and horizontal visibility graphs will be applied to compute a weighted adjacency matrix consisting of all the pairwise interdependences between EEG signals, in order to characterize the integrative and segregative characteristics of the underlying functional brain networks and compare their relationship with the primary outcome. According to a previous estimate, patients with consciousness disorders undergoing cEEG have a 75% survival rate; while patients w/o cEEG 61%. Using a power of 0.8, an α error of 0.05, and a 2-side approach, 2x174 patients would be needed to detect this significant difference in survival.
Expected impact: This study will clarify if cEEG monitoring has a significant impact on functional outcome and define its cost effectiveness, and if network EEG analysis has a role in outcome prognostication. The results of this study will have a considerable potential to influence clinical practice regarding EEG and treatment of patients with altered levels of consciousness. If results will indicate that cEEG contributes to improve outcome, this will lead to the urgent need for implementation of cEEG with consecutive substantial impact on health care and resource allocation in larger Swiss and European hospitals.
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This study's enrollment of 404 is above the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.
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Exclusion Criteria:
Patients randomized to continuous EEG will be recorded with at least 21 electrodes placed according to the international 10-20 system; occasionally, a reduced montage will be allowed in patients with extensive neurosurgical scars, according to good common practice. Recordings will last a minimum of 30 and a maximum of 48 hours. During this time, one interruption to a maximum of two hours for diagnostic purposes will be allowed. Reactivity testing using auditory and nociceptive stimuli will be performed at least twice during the recording time. Recordings will be visually interpreted by certified electroencephalographers (i.e., interpretation of the automated algorithm only won't be allowed) using the 2013 American Clinical neurophysiology nomenclature; interpretations will be communicated within two hours of their completion to the treating team.
Diagnostic Test: continuous EEG (cEEG)
Patients randomized to routine EEG will be recorded with at least 21 electrodes placed according to the international 10-20 system; occasionally, a reduced montage will be allowed in patients with extensive neurosurgical scars, according to good common practice. Recordings will last between 20 and 30 minutes; two recordings will take place over a period of 24 to 48 hours. Reactivity testing using auditory and nociceptive stimuli will be performed once per recording. Recordings will be visually interpreted by certified electroencephalographers using the 2013 American Clinical neurophysiology nomenclature, as for the experimental intervention, and the interpretation will be communicated within two hours of its completion to the treating team.
Diagnostic Test: routine EEG (rEEG)
differential use of continuous versus routine EEG
differential use of continuous versus routine EEG
Mortality
Fatality rate
Time frame: 6 months
Functional outcome 1
Functional outcome using the modified Rankin Scale (mRS) (ordinal)
Time frame: 4 weeks, 6 months
Functional outcome 2
Functional outcome using the Cerebral Performance Categories (CPC) (ordinal)
Time frame: 4 weeks, 6 months
Work/School
Assessment of ability to go back to work/school if previously working/at school (proportion)
Time frame: 4 weeks, 6 months
Seizure detection rate
Seizure detection rate (proportion)
Time frame: within 60 hours
Status Epilepticus detection rate
Status Epilepticus detection rate (proportion)
Time frame: within 60 hours
Time to detection of seizure
Time to detection of seizure after the start of EEG recording (continuous variable)
Time frame: within 60 hours
Time to detection of status epilepticus
Time to detection of status epilepticus after the start of EEG recording (continuous variable)
Time frame: within 60 hours
Presence of clinical signs of seizures
Presence of clinical signs of seizures (continuous variable)
Time frame: within 60 hours
Detection of interictal epileptiform features
Detection of interictal epileptiform features (categorical)
Time frame: within 60 hours
Rate of Infections
Rate of in-hospital infections requiring antibiotic treatment at 4 weeks after first EEG (proportion)
Time frame: 4 weeks
Need of mechanical ventilation
Need of mechanical ventilation after first EEG (proportion variable)
Time frame: 4 weeks
Duration of mechanical ventilation
Duration of mechanical ventilation after first EEG (continuous variable)
Time frame: 4 weeks
Duration of ICU and hospital stay
Duration of ICU and hospital stay (continuous variable)
Time frame: 4 weeks, 6 months
Patient destination
Patient destination after acute facility (home, rehab, nursing home, other; categorical)
Time frame: 4 weeks, 6 months
Change in clinical patients' management
Change in clinical patient management (i.e., antiepileptic drugs (AED) introduced or stopped, AED increased or decreased, brain imaging procedure order) occurring during the 60 hours following the start of the first EEG (categorical).
Time frame: 60 hours
Correlation between quantitative EEG and primary outcome
Correlation between quantitative EEG and primary outcome
Time frame: 6 months
Hospitalization costs
Global hospitalization costs intended as amount billed for each patient's acute hospital stay, assessed through the billing department of each hospital (continuous variable - stratified by site)
Time frame: 6 months
Plan to share: No
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