Amplitude-integrated EEG in Improvement of Seizure Detection and Prognostication in Children With TBI
aEEG
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?
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 1, 2018
February 1, 2018
12 months
November 10, 2017
February 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Determine whether aEEG background activity correlates with patients' neurological outcome.
18 months
Study Arms (1)
Children with moderate to severe TBI
Interventions
Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.
Eligibility Criteria
Patients admitted to the Pediatric Intensive Care Unit
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geneviève Du Pont-Thibodeau, MD, MSc
Sainte-Justine University Hospital Research Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pediatric intensivist
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 17, 2017
Study Start
February 5, 2018
Primary Completion
February 1, 2019
Study Completion
February 1, 2020
Last Updated
March 1, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share