Status EpilepticusNCT02383745
EEG in In-hospital Patients With Seizure or Altered Mental State
An observational study of Status Epilepticus and Seizure, run by Kuopio University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Status Epilepticus, Seizure, Altered Mental Status
- What is being tested?
- Acute EEG with fast EEG electrode
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2014to 18 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In-hospital patients, who have seizure or altered mental state and have been consulted by MET-team
Who may be able to join
- In-hospital patients who have a seizure or altered mental state and are going to be treated in ICU
Who cannot join
- Patiets that are not going to be treated in ICU
- Patients with a Do Not Attempt to Resuscitate - decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating EEG Into Acute Medicine: EEG in In-hospital Patients With Seizure or Altered Mental State Who Have Been Consulted by Medical Emergency Team
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.
- Conditions
- Status Epilepticus, Seizure, Altered Mental Status
- Being tested
- Acute EEG with fast EEG electrode
- Keywords
- Acute EEG, status epilepticus, seizure
- Medical subject headings
- Status Epilepticus, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute EEG with fast EEG electrodeOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of EEG abnormalities detected
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start1 Dec 2014
- Primary completion30 Jun 2016
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esa Mervaala, MD, PhD,professor, Study director, Professor in Clinical Neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383745
- Sponsor's protocol ID
- KUH507T011
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2015
- Last updated
- 18 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating EEG Into Acute Medicine: EEG in In-hospital Patients With Seizure or Altered Mental State Who Have Been Consulted by Medical Emergency Team
- ClinicalTrials.gov ID
- NCT02383745
- Acronym / sponsor ID
- KUH507T011
- Conditions
- Status Epilepticus, Seizure, Altered Mental Status
- Keywords
- Acute EEG, status epilepticus, seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In-hospital patients, who have seizure or altered mental state and have been consulted by MET-team
Key inclusion criteria (1 listed)
- In-hospital patients who have a seizure or altered mental state and are going to be treated in ICU
Key exclusion criteria (2 listed)
- Patiets that are not going to be treated in ICU
- Patients with a Do Not Attempt to Resuscitate - decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute EEG with fast EEG electrode | Other | – |
Primary outcome
Quantity of EEG abnormalities detected
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esa Mervaala, MD, PhD,professor study director
Professor in Clinical Neurophysiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus and Seizure, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of EEG abnormalities detected (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.