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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Altered Level of Consciousness
• Brain Diseases
• Consciousness Disorders
• Encephalopathy
• Epilepsy
• Non-epileptic Seizures
• Seizures
• Status Epilepticus

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