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Detecting Non-convulsive Seizures in the Paediatric Intensive Care Unit

NCT03856775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2023-04-11

No results posted yet for this study

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.

Conditions

  • Non-convulsive Seizures

Interventions

DEVICE

Quantitative EEG and Seizure detector

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.

Sponsors & Collaborators

Principal Investigators

  • Kevin Jones, MD FRCPC · McMaster University

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2023-01-30
Completion
2023-01-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03856775 on ClinicalTrials.gov