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Feasibility of Mini-EEG in the Prehospital Setting

Feasibility of Mini-EEG in the Prehospital Setting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02329028
Enrollment
23
Registered
2014-12-31
Start date
2015-01-31
Completion date
Unknown
Last updated
2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma, Epilepsy

Keywords

Emergency Care, Prehospital, Electroencephalography, Coma

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)

Interventions

DEVICEPrehospital mini-EEG

Observational

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Unconsciousness resulting in activation of the local EMS units

Exclusion criteria

* Cardiac arrest * Traumatic unconsciousness * Transient unconsciousness

Design outcomes

Primary

MeasureTime frameDescription
Signal interpretability60 minevaluated by a physician (ex 0=unworthy, 1=interfered, 2=good quality)
Device ease-of-use60 minevaluated by ems field staff (0=not fit for field use ....... 5=optimal for field use)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026