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CAPTURE: eegCap Application in Paediatrics wiTh redUced GCS in REsus

Sponsor
University College Cork (Other)
Overall Status
Recruiting
CT.gov ID
NCT05259891
Collaborator
(none)
20
Enrollment
1
Location
16.9
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    See study protocol attached

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus
    Actual Study Start Date :
    Jul 5, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. The percentage of children who had EEG monitoring applied within twenty minutes and obtainment of an interpretable EEG recording with less than 25% artefact. [Anticipated 12 month study period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Months to 176 Months
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cork University Hospital (CUH) Cork Munster Ireland T12 DC4A

    Sponsors and Collaborators

    • University College Cork

    Investigators

    • Principal Investigator: Deirdre Murray, UCC and INFANT Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Deirdre Murray, Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital, University College Cork
    ClinicalTrials.gov Identifier:
    NCT05259891
    Other Study ID Numbers:
    • DM01/UCC21
    First Posted:
    Mar 2, 2022
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Deirdre Murray, Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital, University College Cork
    EEG
    Emergency Department
    Paediatrics
    Reduced Glasgow Coma Scale (GCS)
    Additional relevant MeSH terms:
    Seizures
    Brain Diseases
    Status Epilepticus
    Consciousness Disorders

    Study Results

    No Results Posted as of Mar 2, 2022