Feasibility of Mini-EEG in the Prehospital Setting

NCT ID: NCT02329028

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31

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)

Conditions

Epilepsy; Coma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prehospital mini-EEG

Feasibility of prehospital EEG device in unconscious patients.

Prehospital mini-EEG

Intervention Type: DEVICE

Observational

Interventions

Prehospital mini-EEG

Observational

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria

• Cardiac arrest
• Traumatic unconsciousness
• Transient unconsciousness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Johannes Björkman

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Silfvast, MD, Ph.D

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Tapani Salmi, MD, Ph.D.

Role: STUDY_DIRECTOR

Helsinki University Central Hospital

Johannes Björkman, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Countries

Finland

Other Identifiers

150/13/03/02/2013

Identifier Type: -

Identifier Source: org_study_id