eegCap Application in Paediatrics wiTh redUced GCS in REsus

NCT05259891 | Completed DMC

• 1 other identifier: DM01/UCC21
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus; Altered Level of Consciousness; Non-epileptic Seizures; Epilepsy; Encephalopathy

Keywords

EEG; Emergency Department; Paediatrics; Reduced Glasgow Coma Scale (GCS)

Outcome Measures

Primary Outcomes (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

• Age: 0 Months - 176 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population is all children between 0 years and 15 years and 11 months who present to the Resuscitation room of the Emergency Department of Cork University Hospital. Children can have underlying co-morbidities ( eg neurodisability, epilepsy) or be their first time presenting to a hospital.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Cork University Hospital (CUH)

Cork, Munster, T12 DC4A, Ireland

Location

MeSH Terms

Conditions

Status Epilepticus; Consciousness Disorders; Seizures; Epilepsy; Brain Diseases; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Deirdre Murray

  UCC and INFANT Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Consultant Paediatrician, Department of Paediatrics and Child Health and INFANT, UCC, Cork University Hospital

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 2, 2022
• Study Start: July 5, 2021
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

IE (1)