McMaster Children's Hospital
Hamilton, Ontario, L8S4K1, Canada
NCT Number: NCT03856775
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.
Looking for future studies?
Notify Me1 month–18 year
All sexes
Observational
Hamilton, Ontario, L8S4K1, Canada
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Quantitative EEG
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.
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.
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.
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 1 year
The outcome of mortality, will be analyzed descriptively.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Time frame: 1 year
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Time frame: 1year
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
Time frame: 1 year
Will be analyzed descriptively. Estimations will be made with 95% confidence intervals
McMaster University
Other
Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit: A Pilot Study of Another Approach
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01291992
Non-convulsive Seizures
London, Ontario, Canada
View Trial Details