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

Traumatic Brain Injury Clinical Trial

— aEEG  

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03343964
• Other study ID #: CHUSJ 2018-1556
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2017
• Last updated: February 27, 2018
• Start date: February 5, 2018
• Est. completion date: February 2020

Study information

• Verified date: February 2018
• Source: St. Justine's Hospital
• Contact: Ilona Shemyakina, BSc
• Phone: 514-345-4931
• Email: ilona.shemyakina[@]recherche-ste-justine.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Seizures
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Genevieve Du Pont-Thibodeau

Country where clinical trial is conducted

Canada, 

Outcome

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