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

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?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03343964
Acronym
aEEG
Enrollment
45
Registered
2017-11-17
Start date
2018-02-05
Completion date
2020-02-29
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

aEEG, cEEG

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.

Interventions

DIAGNOSTIC_TESTAmplitude-integrated electroencephalography

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

Sponsors

Genevieve Du Pont-Thibodeau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 TBI18 monthsPICU physicians should correctly detect \> 70% of all subclinical seizures. False positives rates should be \< 20%.

Secondary

MeasureTime frameDescription
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 monthsAfter 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 monthsContinuous and reactive backgrounds should correlate with a good neurological outcome. Low voltage, discontinuous or burst suppression backgrounds should correlate with a poor neurological outcome.

Countries

Canada

Contacts

Primary ContactIlona Shemyakina, BSc
ilona.shemyakina@recherche-ste-justine.qc.ca514-345-4931
Backup ContactLucy Clayton, MSc
lucy.clayton@recherche-ste-justine.qc.ca514-345-4931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026