Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02344706

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Status Epilepticus	Device: Registration of EEG

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Mini-EEG, NCSE Unconscious patients due to seizures, of whom EEG is registered	Device: Registration of EEG EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.

Arm

Intervention/Treatment

Mini-EEG, NCSE

Unconscious patients due to seizures, of whom EEG is registered

Device: Registration of EEG

EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.

Outcome Measures

Primary Outcome Measures

Diagnostic value of EEG [60min]
EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unconsciousness due to seizures in the prehospital field

Exclusion Criteria:

Cardiac arrest
Traumatic unconsciousness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

Study Director: Tom Silfvast, MD, Phd, Helsinki University Central Hospital
Principal Investigator: Johannes Björkman, MD, Helsinki University Central Hospital
Study Director: Salmi Tapani, MD, PHD, Helsinki University Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johannes Björkman, Resident, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT02344706

Other Study ID Numbers:

237/3 03.12.2012

First Posted:

Jan 26, 2015

Last Update Posted:

Aug 8, 2018

Last Verified:

Aug 1, 2018

Keywords provided by Johannes Björkman, Resident, Helsinki University Central Hospital

Emergency Care, Prehospital

Coma

Electroencephalography

Additional relevant MeSH terms:

Status Epilepticus

Study Results

No Results Posted as of Aug 8, 2018