Continuous EEG Randomized Trial in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03129438
• Date of registration: 17/04/2017
• Prospective Registration: Yes
• Primary sponsor: Andrea Rossetti, MD
• Public title: Continuous EEG Randomized Trial in Adults CERTA
• Scientific title: Impact on Clinical Outcome of Continuous Video-electroencephalography (cEEG) Monitoring in Patients With Disorders of Consciousness: A Randomized Controlled Trial
• Date of first enrolment: April 25, 2017
• Target sample size: 404
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03129438
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Andrea O Rossetti, MD
• Affiliation: Centre Hospitalier Universitaire Vaudois

Key inclusion & exclusion criteria

Inclusion Criteria:

- In-patients aged =18 years, treated in an ICU or intermediate care unit

- Alteration of mental state of any etiology (i.e., primarily cerebral or not), with
Glasgow-coma scale inferior or equal to 11 or FOUR score inferior or equal to 12.

- Need of an EEG to exclude seizures or SE, or to evaluate prognosis as per the treating
physician or the consulting neurologist.

- Informed consent obtained for research in emergency situation according to Human
Research Act (HRA) art 30-31 at the time of inclusion

Exclusion Criteria:

- Clinical and/or electrographic status epilepticus < 96h before randomization

- Clinical and/or electrographic seizure < 36h before randomization

- Palliative care situation, in which detection of SE or seizures would not have any
impact on the patient's care.

- High likelihood of needing a surgical intervention or an invasive diagnostic procedure
within the next 48 hours according to the treating physician (as this would require
cEEG removal).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

EEG With Abnormally Slow Frequencies

Outcome, Fatal

EEG With Periodic Abnormalities

Coma

Intervention(s)

Diagnostic Test: continuous EEG (cEEG)

Diagnostic Test: routine EEG (rEEG)

Primary Outcome(s)

Mortality [Time Frame: 6 months]

Secondary Outcome(s)

Duration of ICU and hospital stay [Time Frame: 4 weeks, 6 months]

Hospitalization costs [Time Frame: 6 months]

Work/School [Time Frame: 4 weeks, 6 months]

Need of mechanical ventilation [Time Frame: 4 weeks]

Change in clinical patients' management [Time Frame: 60 hours]

Presence of clinical signs of seizures [Time Frame: within 60 hours]

Seizure detection rate [Time Frame: within 60 hours]

Status Epilepticus detection rate [Time Frame: within 60 hours]

Duration of mechanical ventilation [Time Frame: 4 weeks]

Correlation between quantitative EEG and primary outcome [Time Frame: 6 months]

Detection of interictal epileptiform features [Time Frame: within 60 hours]

Functional outcome 2 [Time Frame: 4 weeks, 6 months]

Rate of Infections [Time Frame: 4 weeks]

Time to detection of seizure [Time Frame: within 60 hours]

Time to detection of status epilepticus [Time Frame: within 60 hours]

Patient destination [Time Frame: 4 weeks, 6 months]

Functional outcome 1 [Time Frame: 4 weeks, 6 months]

Secondary ID(s)

2017_00268

Source(s) of Monetary Support

Please refer to primary and secondary sponsors