Amplitude-integrated EEG in Improvement of Seizure Detection and Prognostication in Children With TBI (aEEG)

Can Bedside Amplitude-integrated EEG Improve Seizure Detection and Prognostication in Children With Traumatic Brain Injury in a Hospital With Limited Access to Conventional EEG?

The goal of this study is to determine whether the addition of aEEG to cEEG in clinical practice does in fact help PICU physicians detect subclinical seizures in this population.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: Amplitude-integrated electroencephalography

Detailed Description

Children with moderate to severe TBI are at risk of significant long-term neurological sequelae. Careful post-injury management is crucial in optimizing their recovery. Seizures are a frequent complication. They are associated with worse outcome and require prompt intervention. However, they are often subclinical and are only detectable by gold-standard conventional electroencephalography (cEEG); a costly, complex monitoring device that is not readily available 24/7 in many pediatric intensive care units (PICUs) and can only be interpreted by neurologists. On average, PICUs obtain only 1-2 cEEG reports per day from neurologists and this can lead to significant delays in seizure identification and treatment. Amplitude-integrated EEG (aEEG) is a compressed form of real-time cEEG monitoring that can be added to cEEG monitoring. It is more easy to interpret and can be taught to PICU providers with limited training. It is a promising complementary tool that could help PICU physicians identify subclinical seizures and treat seizures more promptly. This could significantly improve the global outcome of this vulnerable population.

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Contact: Ilona Shemyakina, BSc; Phone Number: 4053 15143454931; Email: ilona.shemyakina@recherche-ste-justine.qc.ca
      • Principal Investigator: Geneviève Du Pont-Thibodeau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Pediatric Intensive Care Unit

Description

Inclusion Criteria:

• moderate to severe TBI defined by a post-resuscitation Glasgow Coma Scale (GCS) of 3-8 (severe) or 9-12 (moderate), this includes those with accidental TBI, abusive head trauma, and cases of polytrauma
• decision by the primary medical team to initiate cEEG monitoring

Exclusion Criteria:

• patients for whom it is impossible to record cEEG for any reason will be excluded from the study
• premature neonates
• brain death or suspected brain death at PICU entry
• unavailable equipment for cEGG and/or aEEG
• consent to participate denied by parents and/or patient

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with moderate to severe TBI	Diagnostic test: Amplitude-integrated electroencephalography; Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of PICU physicians at detecting seizures when using aEEG in real-life clinical setting during the continuous EEG monitoring of patients with moderate to severe TBI	PICU physicians should correctly detect > 70% of all subclinical seizures. False positives rates should be < 20%.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether a 2-hour aEEG teaching session is sufficient for PICU physicians to achieve similar seizure detection rates as experts in aEEG interpretation.	After a 2 hour aEEG training session, PICU physicians should have similar sensitivity and false positive rates as experts in aEEG.	18 months
Determine whether aEEG background activity correlates with patients' neurological outcome.	Continuous and reactive backgrounds should correlate with a good neurological outcome. Low voltage, discontinuous or burst suppression backgrounds should correlate with a poor neurological outcome.	18 months

Collaborators and Investigators

• Sponsor: Genevieve Du Pont-Thibodeau
• Investigators: Principal Investigator: Geneviève Du Pont-Thibodeau, MD, MSc, Sainte-Justine University Hospital Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: aEEG, cEEG
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic; Seizures
• Other Study ID Numbers: CHUSJ 2018-1556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No