Clinical trial NCT03343964: Amplitude-integrated EEG in Improvement of Seizure Detection and Prognostication in Children With TBI
Official title: 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?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: aEEG, cEEG
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 45
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Pediatric Intensive Care Unit

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Determine whether a 2-hour aEEG teaching session is sufficient for PICU physicians to achieve similar seizure detection rates as experts in aEEG interpretation.
timeFrame: 18 months
measure: Determine whether aEEG background activity correlates with patients' neurological outcome.
timeFrame: 18 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
affiliation: Sainte-Justine University Hospital Research Centre
name: Geneviève Du Pont-Thibodeau, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: