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

• Conditions: Traumatic Brain Injury
• Interventions: Diagnostic Test: Amplitude-integrated electroencephalography

• Registration Number: NCT03343964
• Lead Sponsor: Genevieve Du Pont-Thibodeau

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.

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-10
• Study First Posted: 2017-11-17
• Status Verified: 2018-02
• Study Start: 2018-02-05
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-01
• Primary Completion: 2019-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with moderate to severe TBI	Amplitude-integrated electroencephalography	-

Primary Outcome Measures

Name	Time	Method
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	18 months	PICU physicians should correctly detect \> 70% of all subclinical seizures. False positives rates should be \< 20%.

Secondary Outcome Measures

Name	Time	Method
Determine whether a 2-hour aEEG teaching session is sufficient for PICU physicians to achieve similar seizure detection rates as experts in aEEG interpretation.	18 months	After a 2 hour aEEG training session, PICU physicians should have similar sensitivity and false positive rates as experts in aEEG.
Determine whether aEEG background activity correlates with patients' neurological outcome.	18 months	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.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada