Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

NCT02344706 | Unknown DMC

• 1 other identifier: 237/3 03.12.2012
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy; Status Epilepticus

Keywords

Emergency Care, Prehospital; Coma; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• Diagnostic value of EEG

  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)

  60min

Study Arms (1)

Mini-EEG, NCSE

Unconscious patients due to seizures, of whom EEG is registered

Device: Registration of EEG

Interventions

Registration of EEG DEVICE

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

Mini-EEG, NCSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients unconscious due to seizures in the prehospital field

You may qualify if:

• Unconsciousness due to seizures in the prehospital field

You may not qualify if:

• Cardiac arrest
• Traumatic unconsciousness

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Epilepsy; Status Epilepticus; Coma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Seizures; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations

Study Officials

• Tom Silfvast, MD, Phd

  Helsinki University Central Hospital

  STUDY DIRECTOR

• Johannes Björkman, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Salmi Tapani, MD, PHD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Johannes Björkman, MD

CONTACT

094711; johannes.bjorkman@helsinki.fi

Tom Silfvast, MD, PhD

CONTACT

094711

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: December 1, 2018
• Primary Completion: February 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 8, 2018

Record last verified: 2018-08