Feasibility of Mini-EEG in the Prehospital Setting

The EEG is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. Presently, EEG is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. Standard EEG devices are large and their operation require meticulous application of several leads. The department of clinical neurophysiology at Helsinki University Central Hospital has developed a mini-EEG device for use in the emergency department as well as in the prehospital setting. The aims of this pilot study is to evaluate the feasibility of the mini-EEG in the prehospital setting. Patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. The mini--EEG device is to be used by a specially trained emergency medical supervisor. EEG is otherwise obtained in a normal fashion, but only three electrodes are used. The sample size is 30. Data are collected as a part of the clinical work in daily practice. The aim is to collect observational data on feasibility, no clinical interventions will be performed based on the EEG. No funding is needed as data is collected during daily work.

The mini-EEG is a prototype EEG/EKG-adapter, designed by Helsinki Univeristy Central Hospital, and as such, does not have a trade name. It is to be connected to a monitor/defibrillator used by the EMS personel, currently the LifePak 15, manufactured by Physio-Control, Redmond, WA 98052. (www.physio-control.com)

Study Overview

• Status: Completed
• Conditions: Epilepsy; Coma
• Intervention / Treatment: Device: Prehospital mini-EEG

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Unconscious patients in the prehospital field

Description

Inclusion Criteria:

• Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria:

• Cardiac arrest
• Traumatic unconsciousness
• Transient unconsciousness

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prehospital mini-EEG; Feasibility of prehospital EEG device in unconscious patients.	Device: Prehospital mini-EEG; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signal interpretability	evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)	60 min
Device ease-of-use	evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)	60 min

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Johannes Björkman, MD, Helsinki University Central Hospital; Study Director: Tom Silfvast, MD, Ph.D, Helsinki University Central Hospital; Study Director: Tapani Salmi, MD, Ph.D., Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Electroencephalography; Coma; Emergency Care, Prehospital
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 150/13/03/02/2013