Traumatic Brain InjuryaEEGNCT03343964
Amplitude-integrated EEG in Improvement of Seizure Detection and Prognostication in Children With TBI
An observational study of Traumatic Brain Injury, run by Genevieve Du Pont-Thibodeau at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Amplitude-integrated electroencephalography
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2018to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients admitted to the Pediatric Intensive Care Unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Ilona Shemyakina, BSc, 15143454931 ext. 4053, ilona.shemyakina@recherche-ste-justine.qc.ca
Geneviève Du Pont-Thibodeau, MD
About this study
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?
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Amplitude-integrated electroencephalography
- Keywords
- aEEG, cEEG
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplitude-integrated electroencephalographyDiagnostic test
Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Children with moderate to severe TBI | Not described Receives: Diagnostic Test: Amplitude-integrated electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
After a 2 hour aEEG training session, PICU physicians should have similar sensitivity and false positive rates as experts in aEEG.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start5 Feb 2018
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genevieve Du Pont-Thibodeau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Genevieve Du Pont-Thibodeau, St. Justine's Hospital
- Investigators
- Geneviève Du Pont-Thibodeau, MD, MSc, Principal investigator, Sainte-Justine University Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343964
- Sponsor's protocol ID
- CHUSJ 2018-1556
- Acronym
- aEEG
- Status last verified
- Feb 2018
- First submitted
- 10 Nov 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT03343964
- Acronym / sponsor ID
- aEEG / CHUSJ 2018-1556
- Conditions
- Traumatic Brain Injury
- Keywords
- aEEG, cEEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Genevieve Du Pont-ThibodeauUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with moderate to severe TBI | – | Diagnostic Test: Amplitude-integrated electroencephalography |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to the Pediatric Intensive Care Unit
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amplitude-integrated electroencephalographyAmplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring. | Diagnostic test | Children with moderate to severe TBI |
Primary outcome
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
Time frame: 18 months
PICU physicians should correctly detect > 70% of all subclinical seizures. False positives rates should be < 20%.
2 secondary outcomes
Determine whether a 2-hour aEEG teaching session is sufficient for PICU physicians to achieve similar seizure detection rates as experts in aEEG interpretation.
Time frame: 18 months
Determine whether aEEG background activity correlates with patients' neurological outcome.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève Du Pont-Thibodeau, MD, MSc principal investigator
Sainte-Justine University Hospital Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Genevieve Du Pont-Thibodeau at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilona Shemyakina, BSc (514-345-4931 ext. 4053, ilona.shemyakina@recherche-ste-justine.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.