Continuous vs Routine Electroencephalogram in Critically Ill Adults With Altered Consciousness and No Recent Seizure: A Multicenter Randomized Clinical Trial

Andrea O Rossetti, Kaspar Schindler, Raoul Sutter, Stephan Rüegg, Frédéric Zubler, Jan Novy, Mauro Oddo, Loane Warpelin-Decrausaz, Vincent Alvarez, Andrea O Rossetti, Kaspar Schindler, Raoul Sutter, Stephan Rüegg, Frédéric Zubler, Jan Novy, Mauro Oddo, Loane Warpelin-Decrausaz, Vincent Alvarez

Abstract

Importance: In critically ill patients with altered consciousness, continuous electroencephalogram (cEEG) improves seizure detection, but is resource-consuming compared with routine EEG (rEEG). It is also uncertain whether cEEG has an effect on outcome.

Objective: To assess whether cEEG is associated with reduced mortality compared with rEEG.

Design, setting, and participants: The pragmatic multicenter Continuous EEG Randomized Trial in Adults (CERTA) was conducted between 2017 and 2018, with follow-up of 6 months. Outcomes were assessed by interviewers blinded to interventions.The study took place at 4 tertiary hospitals in Switzerland (intensive and intermediate care units). Depending on investigators' availability, we pragmatically recruited critically ill adults having Glasgow Coma Scale scores of 11 or less or Full Outline of Responsiveness score of 12 or less, without recent seizures or status epilepticus. They had cerebral (eg, brain trauma, cardiac arrest, hemorrhage, or stroke) or noncerebral conditions (eg, toxic-metabolic or unknown etiology), and EEG was requested as part of standard care. An independent physician provided emergency informed consent.

Interventions: Participants were randomized 1:1 to cEEG for 30 to 48 hours vs 2 rEEGs (20 minutes each), interpreted according to standardized American Clinical Neurophysiology Society guidelines.

Main outcomes and measures: Mortality at 6 months represented the primary outcome. Secondary outcomes included interictal and ictal features detection and change in therapy.

Results: We analyzed 364 patients (33% women; mean [SD] age, 63 [15] years). At 6 months, mortality was 89 of 182 in those with cEEG and 88 of 182 in those with rEEG (adjusted relative risk [RR], 1.02; 95% CI, 0.83-1.26; P = .85). Exploratory comparisons within subgroups stratifying patients according to age, premorbid disability, comorbidities on admission, deeper consciousness reduction, and underlying diagnoses revealed no significant effect modification. Continuous EEG was associated with increased detection of interictal features and seizures (adjusted RR, 1.26; 95% CI, 1.08-1.15; P = .004 and 3.37; 95% CI, 1.63-7.00; P = .001, respectively) and more frequent adaptations in antiseizure therapy (RR, 1.84; 95% CI, 1.12-3.00; P = .01).

Conclusions and relevance: This pragmatic trial shows that in critically ill adults with impaired consciousness and no recent seizure, cEEG leads to increased seizure detection and modification of antiseizure treatment but is not related to improved outcome compared with repeated rEEG. Pending larger studies, rEEG may represent a valid alternative to cEEG in centers with limited resources.

Trial registration: ClinicalTrials.gov Identifier: NCT03129438.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Rossetti reported grants from Swiss National Scientific Found during the conduct of the study. Dr Sutter reported grants from the Swiss National Foundation (320030_169379) during the conduct of the study; grants from the Research Fund of the University of Basel, Scientific Society Basel, the Bangerter-Rhyner Foundation, and UCB Pharma; and holds stocks from Alcon, Johnson & Johnson, Novartis, and Roche outside the submitted work. Dr Rüegg reported grants from Swiss National Science Foundation during the conduct of the study. Dr Zubler reported grants from Swiss National Science Foundation during the conduct of the study. Dr Novy reported personal fees from UCB, Eiai, Arvelle Tx, Desitin, and Sandoz outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Study Flowchart
Figure 1.. Study Flowchart
The number of screened patients was not recorded. cEEG indicates continuous electroencephalogram; rEEG, routine EEG.
Figure 2.. Effect Modification Regarding the Relative…
Figure 2.. Effect Modification Regarding the Relative Risk of Mortality at 6 Months for Continuous Electroencephalogram (EEG)
FOUR indicates Full Outline of Responsiveness score; GCS, Glasgow Coma Scale score; mRS, modified Rankin Scale.

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