Feasibility of Mini-EEG in the Prehospital Setting

Completed

• Conditions: Coma; Epilepsy
• Interventions: Device: Prehospital mini-EEG

• Registration Number: NCT02329028
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-12-29
• Study First Posted: 2014-12-31
• Study Start: 2015-01
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria

• Cardiac arrest
• Traumatic unconsciousness
• Transient unconsciousness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehospital mini-EEG	Prehospital mini-EEG	Feasibility of prehospital EEG device in unconscious patients.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland