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NCT05259891 Clinical Trial

eegCap Application in Paediatrics wiTh redUced GCS in REsus

Epilepsy Clinical Trial

— CAPTURE  

Official title:
CAPTURE:eegCap Application in Paediatrics wiTh redUced GCS in REsus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05259891
Other study ID # DM01/UCC21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2021
Est. completion date June 20, 2022

Study information
Verified date May 2023
Source University College Cork
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

See study protocol attached

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 20, 2022
Est. primary completion date June 20, 2022
Accepts healthy volunteers
Gender All
Age group 0 Months to 176 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Ireland Cork University Hospital (CUH) Cork Munster

Sponsors (1)
Lead Sponsor Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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