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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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?

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Diagnostic Test: Amplitude-integrated electroencephalography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with moderate to severe TBI<br> | Diagnostic Test: Amplitude-integrated electroencephalography<br>* Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aEEG, cEEG