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Completed

NCT Number: NCT02329028

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unconsciousness resulting in activation of the local EMS units

Exclusion criteria

  • Cardiac arrest
  • Traumatic unconsciousness
  • Transient unconsciousness

Treatment and study plan

Prehospital mini-EEG

Device

Observational

Primary outcomes

  1. Signal interpretability

    Time frame: 60 min

    evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)

  2. Device ease-of-use

    Time frame: 60 min

    evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
First posted
Dec 31, 2014
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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