Non-convulsive SeizuresNCT03856775
Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit
An observational study of Non-convulsive Seizures, run by McMaster University at 1 site in Canada.
Trial summary
The objective of this study is to determine if paediatric intensive care nurses and physicians can identify non-convulsive seizures in critically ill children using quantitative electroencephalography (EEG), in real time at the bedside. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Non-convulsive Seizures
- What is being tested?
- Quantitative EEG and Seizure detector
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 30 Jan 2023
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: A sample of 30 patients will be enrolled in the study and include children between the ages of 1 month and 18 years who meet criteria for continuous EEG monitoring in the paediatric intensive care unit at McMaster Children's Hospital.
Who may be able to join
- Infants and children (1 month - 18 years of age)
- Admission to McMaster Children's Hospital paediatric intensive care unit.
- Fulfill indications for Continuous EEG monitoring
- Informed consent received
Who cannot join
- Suspected brain death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit: A Pilot Study of Another Approach
The objective of this study is to determine if paediatric intensive care nurses and physicians can identify non-convulsive seizures in critically ill children using quantitative electroencephalography (EEG), in real time at the bedside. Quantitative EEG is a computer software tool which summarizes large volumes of brain wave electrical activity, called EEG into simple graphs and patterns. This has helped to shorten the EEG reading time.The study will also describe the neurological outcome of children monitored this way and assess if it's possible to use this approach. The investigators hypothesis is that paediatric intensive care nurses and physicians with focused training should be the first to identify non-convulsive seizures at the bedside using quantitative EEG, with reasonable accuracy and reliability. They should be able to confirm their findings with a neurologist to treat seizures quickly without over treatment. Due to the small numbers in this pilot study, the investigators are unlikely to be able to draw definitive conclusions on the clinical effects of this approach on the short- or long-term outcomes. This proof-of-concept study should, enable the investigators to assess if it's possible to use this method for a future multi-centre controlled study.
Read the detailed description
Overall Goals: The overall goals of this research are to: (i) determine the feasibility of studying another approach to the detection of non-convulsive seizures in the paediatric intensive care unit, (ii) determine if paediatric intensive care nurses and non-neurophysiologist critical-care physicians can accurately identify seizures in critically ill children by reading quantitative EEG trends, as well as the positive and negative predictive value and inter-rater reliability of this approach, (iii) explore children's short- and long-term neurological outcomes.
Background: Non-convulsive seizures and non-convulsive status epilepticus are common in children with acute brain injury admitted to paediatric intensive care units. Electrographic seizure burden and status epilepticus contribute to neuronal injury, and worsen functional and quality of life outcomes. Accurate and timely diagnosis and treatment of non-convulsive seizures are essential in these critically ill children.
Purpose: This exploratory study aims to: (i) enable the investigators, after proof of concept, to assess the feasibility of this method, (ii) determine the performance - in real time at the bedside of critically ill children - of caregivers other than neurologists to identify electrographical seizures, using panels of quantitative EEG trends, and (iii) describe the outcome of these children.
Method: This pilot study will be a single-centre prospective open observational study. Thirty consecutive children who meet the specific criteria for continuous EEG in the paediatric intensive care unit at McMaster Children's Hospital will be eligible for enrolment. The paediatric intensive care nurse and resident or fellow will review the quantitative EEG trends to detect seizures at the bedside and complete the seizure log. This will be compared to the seizures detected on the raw EEG data read by the neurologist. Demographic data, baseline, short- and long-term (12-month) questionnaires of each child's global function, quality of life, seizures and brain behaviour will be completed to assess functional and quality of life outcomes. This will include a Seizure questionnaire, the Glasgow Outcome scale, the Paediatric Cerebral Performance Category score, the Paediatric Quality of Life Inventory, the Adaptive Behaviour Assessment System 3, the Child Behaviour Checklist and the Behaviour Rating Inventory of Executive Function 2.
Expertise: The investigator team includes research experts in neurology, epilepsy, neurophysiology, developmental paediatrics, critical care and biostatistics.
Significance: Due to the small numbers in this pilot study, the investigators are unlikely to be able to draw definitive conclusions on the clinical effects of this approach on the short- or long-term outcomes. This proof-of-concept study should enable the investigators to assess the feasibility of this method for a future multi-centre controlled study, which has the potential to revise and considerably improve the method of detecting non-convulsive seizures in the paediatric intensive care unit. If earlier detection and treatment of seizures in critically ill children are feasible, this should lead to improvements in short- and long-term neurological outcome and quality of life. These improvements may substantially benefit the person, family and society while reducing the burden placed on the health care system.
- Conditions
- Non-convulsive Seizures
- Being tested
- Quantitative EEG and Seizure detector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative EEG and Seizure detectorDevice
Also called Quantitative EEG
Paediatric intensive care unit nurses, residents or fellows will perform hourly review of a bedside graphical display of the previous hour's epoch of quantitative EEG for seizure patterns. One page of quantitative EEG data represents one hour of recording. The graphical display will include a seizure-detection marker, seizure probability indicator, bilateral rhythmicity spectrogram and bilateral amplitude integrated EEG.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment,
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the rates of recruitment, are 0.8 with 95% confidence intervals of +/- 0.14.
Measured: 2 years
Data form completion
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the data collection, is 0.8 with 95% confidence intervals of +/- 0.14.
Measured: 2 years
Equipment availability
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the equipment availability is 0.8 with 95% confidence intervals of +/- 0.14.
Measured: 2 years
Study completion
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the study-completion is 0.8 with 95% confidence intervals of +/- 0.14.
Measured: 2 years
Secondary outcomes (11)
Sensitivity
The Sensitivity of quantitative electroencephalography read by intensive care nurses and non-neurology expert physicians - to detect electrographical seizures in the paediatric intensive care unit will be estimated against the standard method of seizure detection currently used by neurology experts with continuous electroencephalography.
Measured: 2 years
Specificity
The Specificity of quantitative electroencephalography read by intensive care nurses and non-neurology expert physicians - to detect electrographical seizures in the paediatric intensive care unit will be estimated against the standard method of seizure detection currently used by neurology experts with continuous electroencephalography.
Measured: 2 years
Positive predictive value
The positive predictive value of quantitative electroencephalography read by intensive care nurses and non-neurology expert physicians - to detect electrographical seizures in the paediatric intensive care unit will be estimated against the standard method of seizure detection currently used by neurology experts with continuous electroencephalography.
Measured: 2 years
Negative predictive value
The negative predictive value of quantitative electroencephalography read by intensive care nurses and non-neurology expert physicians - to detect electrographical seizures in the paediatric intensive care unit will be estimated against the standard method of seizure detection currently used by neurology experts with continuous electroencephalography.
Measured: 2 years
Mortality
The outcome of mortality, will be analyzed descriptively.
Measured: 1 year
Glasgow Outcome scale
Higher values represent a worse outcome: 8 - Death, 7 - Vegetative State (VS), 6 - Lower Severe Disability (Lower SD), 5 - Upper Severe Disability (Upper SD), 4 - Lower Moderate Disability (Lower MD), 3 - Upper Moderate Disability (Upper MD), 2 - Lower Good Recovery (Lower GR)
1 - Upper Good Recovery (Upper GR). Will be analyzed descriptively. Estimations will be made with 95% confidence intervals.
Measured: 1 year
Pediatric Cerebral Performance Category score,
Higher values represent a worse outcome: Normal -1 Mild disability -2 Moderate disability -3 Severe disability -4 Coma and vegetative state -5 Death -6. Will be analyzed descriptively. Estimations will be made with 95% confidence intervals.
Measured: 1 year
Pediatric Quality of Life Inventory
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Measured: 1 year
Adaptive Behaviour Assessment System III,
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Measured: 1 year
Child Behaviour Checklist
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Measured: 1year
Behaviour Rating Inventory of Executive Function II
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start1 Aug 2019
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-convulsive SeizuresStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Jones, McMaster University
- Investigators
- Kevin Jones, MD FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856775
- Sponsor's protocol ID
- NIF-18448-R
- Status last verified
- Apr 2023
- First submitted
- 17 Feb 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit: A Pilot Study of Another Approach
- ClinicalTrials.gov ID
- NCT03856775
- Acronym / sponsor ID
- NIF-18448-R
- Conditions
- Non-convulsive Seizures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 Feb 2019 (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 objective of this study is to determine if paediatric intensive care nurses and physicians can identify non-convulsive seizures in critically ill children using quantitative electroencephalography (EEG), in real time at the bedside. Quantitative EEG is a computer software tool which summarizes large volumes of brain wave electrical activity, called EEG into simple graphs and patterns. This has helped to shorten the EEG reading time.The study will also describe the neurological outcome of children monitored this way and assess if it's possible to use this approach. The investigators hypothesis is that paediatric intensive care nurses and physicians with focused training should be the first to identify non-convulsive seizures at the bedside using quantitative EEG, with reasonable accuracy and reliability. They should be able to confirm their findings with a neurologist to treat seizures quickly without over treatment. Due to the small numbers in this pilot study, the investigators are unlikely to be able to draw definitive conclusions on the clinical effects of this approach on the short- or long-term outcomes. This proof-of-concept study should, enable the investigators to assess if it's possible to use this method for a future multi-centre controlled study.
Detailed description
Overall Goals: The overall goals of this research are to: (i) determine the feasibility of studying another approach to the detection of non-convulsive seizures in the paediatric intensive care unit, (ii) determine if paediatric intensive care nurses and non-neurophysiologist critical-care physicians can accurately identify seizures in critically ill children by reading quantitative EEG trends, as well as the positive and negative predictive value and inter-rater reliability of this approach, (iii) explore children's short- and long-term neurological outcomes.
Background: Non-convulsive seizures and non-convulsive status epilepticus are common in children with acute brain injury admitted to paediatric intensive care units. Electrographic seizure burden and status epilepticus contribute to neuronal injury, and worsen functional and quality of life outcomes. Accurate and timely diagnosis and treatment of non-convulsive seizures are essential in these critically ill children.
Purpose: This exploratory study aims to: (i) enable the investigators, after proof of concept, to assess the feasibility of this method, (ii) determine the performance - in real time at the bedside of critically ill children - of caregivers other than neurologists to identify electrographical seizures, using panels of quantitative EEG trends, and (iii) describe the outcome of these children.
Method: This pilot study will be a single-centre prospective open observational study. Thirty consecutive children who meet the specific criteria for continuous EEG in the paediatric intensive care unit at McMaster Children's Hospital will be eligible for enrolment. The paediatric intensive care nurse and resident or fellow will review the quantitative EEG trends to detect seizures at the bedside and complete the seizure log. This will be compared to the seizures detected on the raw EEG data read by the neurologist. Demographic data, baseline, short- and long-term (12-month) questionnaires of each child's global function, quality of life, seizures and brain behaviour will be completed to assess functional and quality of life outcomes. This will include a Seizure questionnaire, the Glasgow Outcome scale, the Paediatric Cerebral Performance Category score, the Paediatric Quality of Life Inventory, the Adaptive Behaviour Assessment System 3, the Child Behaviour Checklist and the Behaviour Rating Inventory of Executive Function 2.
Expertise: The investigator team includes research experts in neurology, epilepsy, neurophysiology, developmental paediatrics, critical care and biostatistics.
Significance: Due to the small numbers in this pilot study, the investigators are unlikely to be able to draw definitive conclusions on the clinical effects of this approach on the short- or long-term outcomes. This proof-of-concept study should enable the investigators to assess the feasibility of this method for a future multi-centre controlled study, which has the potential to revise and considerably improve the method of detecting non-convulsive seizures in the paediatric intensive care unit. If earlier detection and treatment of seizures in critically ill children are feasible, this should lead to improvements in short- and long-term neurological outcome and quality of life. These improvements may substantially benefit the person, family and society while reducing the burden placed on the health care system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- A sample of 30 patients will be enrolled in the study and include children between the ages of 1 month and 18 years who meet criteria for continuous EEG monitoring in the paediatric intensive care unit at McMaster Children's Hospital.
Key inclusion criteria (4 listed)
- Infants and children (1 month - 18 years of age)
- Admission to McMaster Children's Hospital paediatric intensive care unit.
- Fulfill indications for Continuous EEG monitoring
- Informed consent received
Key exclusion criteria (1 listed)
- Suspected brain death
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 |
|---|---|---|
| Quantitative EEG and Seizure detectorAlso: Quantitative EEGPaediatric intensive care unit nurses, residents or fellows will perform hourly review of a bedside graphical display of the previous hour's epoch of quantitative EEG for seizure patterns. One page of quantitative EEG data represents one hour of recording. The graphical display will include a seizure-detection marker, seizure probability indicator, bilateral rhythmicity spectrogram and bilateral amplitude integrated EEG. | Device | – |
Primary outcome
Patient recruitment,
Time frame: 2 years
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the rates of recruitment, are 0.8 with 95% confidence intervals of +/- 0.14.
Data form completion
Time frame: 2 years
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the data collection, is 0.8 with 95% confidence intervals of +/- 0.14.
Equipment availability
Time frame: 2 years
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the equipment availability is 0.8 with 95% confidence intervals of +/- 0.14.
Study completion
Time frame: 2 years
Will be analyzed based on descriptive statistics reported as an estimate of the 95 % confidence intervals. This feasibility study will be considered successful if the study-completion is 0.8 with 95% confidence intervals of +/- 0.14.
11 secondary outcomes
Sensitivity
Time frame: 2 years
Specificity
Time frame: 2 years
Positive predictive value
Time frame: 2 years
Negative predictive value
Time frame: 2 years
Mortality
Time frame: 1 year
Glasgow Outcome scale
Time frame: 1 year
Pediatric Cerebral Performance Category score,
Time frame: 1 year
Pediatric Quality of Life Inventory
Time frame: 1 year
Adaptive Behaviour Assessment System III,
Time frame: 1 year
Child Behaviour Checklist
Time frame: 1year
Behaviour Rating Inventory of Executive Function II
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Non-convulsive Seizures
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Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)
Non-Convulsive Status Epilepticus
Recruiting
The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus
Status Epilepticus, Ictal-interictal Continuum
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.
Kevin Jones, MD FRCPC principal investigator
McMaster University
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 Non-convulsive Seizures, run by McMaster University 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment, (time frame: 2 years). The study lists 4 primary outcomes in all. 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 11 Apr 2023.