Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Non-convulsive Seizures
• Intervention / Treatment: Device: Quantitative EEG and Seizure detector

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 Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

• Study Contact: Name: Kevin Jones, MD FRCPC; Phone Number: 75613 905 521 2100; Email: joneskc@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 years
Mortality	The outcome of mortality, will be analyzed descriptively.	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.	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.	1 year
Pediatric Quality of Life Inventory	Will be analyzed descriptively. Estimations will be made with 95% confidence intervals	1 year
Adaptive Behaviour Assessment System III,	Will be analyzed descriptively. Estimations will be made with 95% confidence intervals	1 year
Child Behaviour Checklist	Will be analyzed descriptively. Estimations will be made with 95% confidence intervals	1year
Behaviour Rating Inventory of Executive Function II	Will be analyzed descriptively. Estimations will be made with 95% confidence intervals	1 year

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 17, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: NIF-18448-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes