Diagnostic Value of Prehospital EEG in Non-convulsive Sta... | NCT02344706

Studies
Diagnostic Value of Prehospital EEG in Non-convulsive Status Epilepticus

NCT02344706

Sponsor

Helsinki University Central Hospital

Status

Unknown status

Last Update Posted

Aug 8, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Epilepsy
Status Epilepticus

Interventions

Registration of EEG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Estimated

Primary Completion Date

Feb 2021Estimated

Completion Date

Jan 1, 2022Estimated

First Submitted Date

Jan 16, 2015

First Submission Date that Met QC Criteria

Jan 22, 2015

First Posted Date

Jan 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2018

Last Update Posted Date

Aug 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johannes Björkman, Resident, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A large proportion of patients (up to 20%) who suffer from an epileptic seizure and remain unconscious suffer from a non-convulsive epileptic seizure. The condition is difficult to diagnose, and impossible without the required instruments. Electroencephalogram is required in the diagnosis of non-convulsive status epilepticus. Presently, the diagnostic value and implementation of such a device in the prehospital field is little studied. The aim of this study is to evaluate the diagnostic value of the acquired electroencephalogram with a prototype EEG/EKG adapter connected to a Physio-Control LifePak 15 defibrillator/monitor. The EEG is registered in a otherwise normal fashion with scalp-electrodes, but only three channels are monitored, as this is deemed sufficient for the prehospital field, as well as for monitoring the epileptic seizures.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mini-EEG, NCSE		Unconscious patients due to seizures, of whom EEG is registered	Device: Registration of EEG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Registration of EEG	Device	EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.	Mini-EEG, NCSE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic value of EEG	EEG signal assessed by a physician educated in interpretation of EEG, use a numeric scale (eg 0=not of value/corrupted, 5=good signal with diagnostic value)	60min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unconsciousness due to seizures in the prehospital field

Exclusion Criteria:

Cardiac arrest
Traumatic unconsciousness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients unconscious due to seizures in the prehospital field

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Johannes Björkman, MD	Contact	094711		johannes.bjorkman@helsinki.fi
Tom Silfvast, MD, PhD	Contact	094711

Overall Officials

Name	Affiliation	Role
Tom Silfvast, MD, Phd	Helsinki University Central Hospital	Study Director
Johannes Björkman, MD	Helsinki University Central Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D013226	Status Epilepticus
D003128	Coma

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D012640	Seizures

Browse Leaves

Not provided

Browse Branches

Not provided