Clinical trial NCT03856775: Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit
Official title: Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit: A Pilot Study of Another Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-convulsive Seizures
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Suspected brain death

Primary outcomes:
measure: Patient recruitment,
timeFrame: 2 years
measure: Data form completion
timeFrame: 2 years
measure: Equipment availability
timeFrame: 2 years
measure: Study completion
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity
timeFrame: 2 years
measure: Specificity
timeFrame: 2 years
measure: Positive predictive value
timeFrame: 2 years
measure: Negative predictive value
timeFrame: 2 years
measure: Mortality
timeFrame: 1 year
measure: Glasgow Outcome scale
timeFrame: 1 year
measure: Pediatric Cerebral Performance Category score,
timeFrame: 1 year
measure: Pediatric Quality of Life Inventory
timeFrame: 1 year
measure: Adaptive Behaviour Assessment System III,
timeFrame: 1 year
measure: Child Behaviour Checklist
timeFrame: 1year
measure: Behaviour Rating Inventory of Executive Function II
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Kevin Jones, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: