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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-05

Study Completion Date

2020-02-29

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.

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with moderate to severe TBI

Amplitude-integrated electroencephalography

Intervention Type DIAGNOSTIC_TEST

Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.

Interventions

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Amplitude-integrated electroencephalography

Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.

Intervention Type DIAGNOSTIC_TEST

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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No