NCT02383745

Brief Summary

In Kuopio University Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. It is easy to set up, records high quality EEG and can detect the most important EEG abnormalities comparable to conventional EEG. This study will address the clinical use of acute EEG with fast electrode set in in-hospital patients who have been consulted by Medical Emergency Team because of seizure or altered mental state of uncertain etiology. Patients are going to be treated in ICU and EEG monitoring will continue for 24 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

March 4, 2015

Last Update Submit

February 17, 2021

Conditions

Keywords

Acute EEGstatus epilepticusseizure

Outcome Measures

Primary Outcomes (1)

  • Quantity of EEG abnormalities detected

    24 hours

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In-hospital patients, who have seizure or altered mental state and have been consulted by MET-team

You may qualify if:

  • In-hospital patients who have a seizure or altered mental state and are going to be treated in ICU

You may not qualify if:

  • Patiets that are not going to be treated in ICU
  • Patients with a Do Not Attempt to Resuscitate - decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70210, Finland

Location

MeSH Terms

Conditions

Status EpilepticusSeizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esa Mervaala, MD, PhD,professor

    Professor in Clinical Neurophysiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 9, 2015

Study Start

December 1, 2014

Primary Completion

June 30, 2016

Study Completion

December 18, 2018

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations