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CompletedNCT02329028Updated Sep 8, 2016

Feasibility of Mini-EEG in the Prehospital Setting

An observational study in Epilepsy and Coma, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-08.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
23
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Epilepsy
  • Coma

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Keywords

  • Emergency Care, Prehospital
  • Electroencephalography
  • Coma
03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's enrollment of 23 is below the median of 101 across 536 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Unconscious patients in the prehospital field

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Unconsciousness resulting in activation of the local EMS units

Exclusion criteria

Exclusion Criteria:

  • Cardiac arrest
  • Traumatic unconsciousness
  • Transient unconsciousness
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
23 participants (actual)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • Prehospital mini-EEG

    Feasibility of prehospital EEG device in unconscious patients.

    Device: Prehospital mini-EEG

Interventions

  • DevicePrehospital mini-EEG

    Observational

06

What researchers measure

Primary outcomes

  1. Signal interpretability

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

    Time frame: 60 min

  2. Device ease-of-use

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

    Time frame: 60 min

07

Study locations

1 site
  • Helsinki University Central Hospital
    Helsinki, 00029, Finland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2015 and a primary completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2014
First posted
Dec 31, 2014
Start
Jan 2015
Primary completionActual
Sep 2016
Last update
Sep 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02329028
Responsible party
Johannes Björkman (Resident, Helsinki University Central Hospital) — Principal investigator
First posted
Dec 31, 2014
Start date
Jan 2015
Primary completion
Sep 2016
Last update
Sep 8, 2016

Study contacts

Tom Silfvast, MD, Ph.D
study director · Helsinki University Central Hospital
Tapani Salmi, MD, Ph.D.
study director · Helsinki University Central Hospital
Johannes Björkman, MD
principal investigator · Helsinki University Central Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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