Feasibility of Mini-EEG in the Prehospital Setting

Epilepsy Clinical Trial

Official title:

Feasibility of Mini-EEG in the Prehospital Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329028
• Other study ID #: 150/13/03/02/2013
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: September 7, 2016
• Start date: January 2015

Study information

• Verified date: September 2016
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria:

• Cardiac arrest

• Traumatic unconsciousness

• Transient unconsciousness

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coma
• Epilepsy

Intervention

Device:
• Prehospital mini-EEG
Observational

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal interpretability	evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)	60 min	No
Primary	Device ease-of-use	evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)	60 min	No