Continuous EEG Randomized Trial in Adults

NCT03129438 | Completed

• 1 other identifier: 2017_00268
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

EEG With Periodic Abnormalities; EEG With Abnormally Slow Frequencies; Coma; Outcome, Fatal

Keywords

continuous EEG; routine EEG; prognosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Fatality rate

  6 months

Secondary Outcomes (17)

• Functional outcome 1

  4 weeks, 6 months

• Functional outcome 2

  4 weeks, 6 months

• Work/School

  4 weeks, 6 months

• Seizure detection rate

  within 60 hours

• Status Epilepticus detection rate

  within 60 hours

Study Arms (2)

continuous EEG (cEEG)

EXPERIMENTAL

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)

routine EEG (rEEG)

ACTIVE COMPARATOR

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)

Interventions

continuous EEG (cEEG) DIAGNOSTIC_TEST

differential use of continuous versus routine EEG

continuous EEG (cEEG)

routine EEG (rEEG) DIAGNOSTIC_TEST

differential use of continuous versus routine EEG

routine EEG (rEEG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Andrea Rossetti, MD: lead

Study Sites (4)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Hôpital du Valais - Site Hôpital de Sion

Sion, Valais, 1951, Switzerland

Location

Universitätsspital

Basel, 4031, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (5)

• Urbano V, Alvarez V, Schindler K, Ruegg S, Ben-Hamouda N, Novy J, Rossetti AO. Continuous versus routine EEG in patients after cardiac arrest: Analysis of a randomized controlled trial (CERTA). Resuscitation. 2022 Jul;176:68-73. doi: 10.1016/j.resuscitation.2022.05.017. Epub 2022 May 30.

  PMID: 35654226 DERIVED

• Urbano V, Novy J, Alvarez V, Schindler K, Ruegg S, Rossetti AO. EEG recording latency in critically ill patients: Impact on outcome. An analysis of a randomized controlled trial (CERTA). Clin Neurophysiol. 2022 Jul;139:23-27. doi: 10.1016/j.clinph.2022.04.003. Epub 2022 Apr 18.

  PMID: 35490437 DERIVED

• Urbano V, Novy J, Schindler K, Ruegg S, Alvarez V, Zubler F, Oddo M, Lee JW, Rossetti AO. Continuous versus routine EEG in critically ill adults: reimbursement analysis of a randomised trial. Swiss Med Wkly. 2021 Mar 16;151:w20477. doi: 10.4414/smw.2021.20477. eCollection 2021 Mar 15.

  PMID: 33793960 DERIVED

• Guinchard M, Warpelin-Decrausaz L, Schindler K, Ruegg S, Oddo M, Novy J, Alvarez V, Rossetti AO. Informed consent in critically ill adults participating to a randomized trial. Brain Behav. 2021 Feb;11(2):e01965. doi: 10.1002/brb3.1965. Epub 2020 Dec 3.

  PMID: 33271000 DERIVED

• Rossetti AO, Schindler K, Sutter R, Ruegg S, Zubler F, Novy J, Oddo M, Warpelin-Decrausaz L, Alvarez V. Continuous vs Routine Electroencephalogram in Critically Ill Adults With Altered Consciousness and No Recent Seizure: A Multicenter Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1225-1232. doi: 10.1001/jamaneurol.2020.2264.

  PMID: 32716479 DERIVED

MeSH Terms

Conditions

Coma

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea O Rossetti, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blind assessment of secondary outcomes at 6 months
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 26, 2017
• Study Start: April 25, 2017
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)