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Clinical Trials/NCT05259891
NCT05259891
Completed
Not Applicable

CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus

University College Cork1 site in 1 country20 target enrollmentJuly 5, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Status Epilepticus
Sponsor
University College Cork
Enrollment
20
Locations
1
Primary Endpoint
The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Children frequently present with altered or reduced consciousness levels to emergency departments. By using EEG monitoring, subclinical seizure activity may be detected, leading to earlier pharmacological intervention and improved outcomes. Post-ictal phases that may be interpreted as seizure activity may become less over-treated. A feasibility study will ascertain if EEG monitoring can be applied successfully in this cohort, within a specified time period, obtaining minimum artefact (defined as < 25% artefact). EEG recordings will not be used to guide clinical management during this feasibility study.

Detailed Description

See study protocol attached

Registry
clinicaltrials.gov
Start Date
July 5, 2021
End Date
June 20, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Deirdre Murray

Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital

University College Cork

Eligibility Criteria

Inclusion Criteria

  • Children between 0 and 15 years and 11 months who present to Resuscitation Room, ED, CUH with a Glasgow Coma Scale (GCS) \< 11 or, a reduction in baseline GCS in the case of children with significant neurodisability at baseline

Exclusion Criteria

  • Polytrauma
  • Open head wounds
  • Unstable airway or requirement for bag and mask ventilation, where cap application would affect clinical management

Outcomes

Primary Outcomes

The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact.

Time Frame: Anticipated 12 month study period

Study Sites (1)

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