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Feasibility of Mini-EEG in the Prehospital Setting

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ClinicalTrials.gov Identifier: NCT02329028
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Johannes Björkman, 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)


Condition or disease Intervention/treatment
Epilepsy Coma Device: Prehospital mini-EEG

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Study Type : Observational [Patient Registry]
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Feasibility of Mini-EEG in the Prehospital Setting
Study Start Date : January 2015
Actual Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
Prehospital mini-EEG
Feasibility of prehospital EEG device in unconscious patients.
Device: Prehospital mini-EEG
Observational




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Unconscious patients in the prehospital field
Criteria

Inclusion Criteria:

  • Unconsciousness resulting in activation of the local EMS units

Exclusion Criteria:

  • Cardiac arrest
  • Traumatic unconsciousness
  • Transient unconsciousness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329028


Locations
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Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Tom Silfvast, MD, Ph.D Helsinki University Central Hospital
Study Director: Tapani Salmi, MD, Ph.D. Helsinki University Central Hospital
Principal Investigator: Johannes Björkman, MD Helsinki University Central Hospital
Additional Information:

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Responsible Party: Johannes Björkman, Resident, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02329028    
Other Study ID Numbers: 150/13/03/02/2013
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Keywords provided by Johannes Björkman, Helsinki University Central Hospital:
Emergency Care, Prehospital
Electroencephalography
Coma
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases