NCT02329028|CompletedDMC
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Sponsor study identifier
observational
23
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
Not reported
Date not reportedThe 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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2014
Actual (reported)December 31, 2014
Actual (reported)January 2015
Date type not reportedThis date has not been verified as actual or estimated.
September 2016
Actual (reported)Signal interpretability
evaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)
60 min
Device ease-of-use
evaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)
60 min
Feasibility of prehospital EEG device in unconscious patients.
Observational
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Unconscious patients in the prehospital field
Helsinki University Central Hospital
Helsinki, 00029, Finland
Tom Silfvast, MD, Ph.D
Helsinki University Central Hospital
Tapani Salmi, MD, Ph.D.
Helsinki University Central Hospital
Johannes Björkman, MD
Helsinki University Central Hospital
23 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2014
First Posted
December 31, 2014
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
EEG@HOME (Phase 3b of the Project, Interviews)
Contact the study team to confirm eligibility.
Primary Completion
September 2016
Actual (reported)Last Updated
September 8, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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