Sudden Cardiac ArrestNCT02349087
EEG in Resuscitated In-hospital Patients
An observational study of Sudden Cardiac Arrest and Seizures, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Arrest, Seizures
- What is being tested?
- Acute EEG with fast applicable EEG electrode
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2014to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In- hospital resuscitated patients, who are going to be treated in ICU after ROSC. Patients with Do Not Attempt to Resuscitate -decision will not be included.
Who may be able to join
- Resuscitated in-hospital patients
Who cannot join
- Patients with Do Not Attempt to Resuscitate-decision
- Patients who are not going to be treated in ICU after resuscitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating EEG Into Acute Medicine: EEG in Resuscitated In-hospital Patients
In Kuopio University Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.
- Conditions
- Sudden Cardiac Arrest, Seizures
- Being tested
- Acute EEG with fast applicable EEG electrode
- Keywords
- EEG, cardiac arrest, resuscitation, seizures
- Medical subject headings
- Death, Sudden, Cardiac, Seizures, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute EEG with fast applicable EEG electrodeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found
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 posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esa Mervaala, MD, PhD,prof, Study director, Clinical Neurophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349087
- Sponsor's protocol ID
- KUH507T010
- Status last verified
- Feb 2021
- First submitted
- 23 Jan 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 Resuscitated In-hospital Patients
- ClinicalTrials.gov ID
- NCT02349087
- Acronym / sponsor ID
- KUH507T010
- Conditions
- Sudden Cardiac Arrest, Seizures
- Keywords
- EEG, cardiac arrest, resuscitation, seizures
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jan 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 Hospital Department of Clinical Neurophysiology there have been designed a fast EEG electrode, that is suitable for acute emergency use. This study will address the clinical use of acute EEG with this fast EEG electrode in in- hospital patients who have been resuscitated due to cardiac arest. After resuscitation patients will be treated in ICU and EEG will be recorded for 24 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In- hospital resuscitated patients, who are going to be treated in ICU after ROSC. Patients with Do Not Attempt to Resuscitate -decision will not be included.
Key inclusion criteria (1 listed)
- Resuscitated in-hospital patients
Key exclusion criteria (2 listed)
- Patients with Do Not Attempt to Resuscitate-decision
- Patients who are not going to be treated in ICU after resuscitation
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 applicable EEG electrode | Device | – |
Primary outcome
24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found
Time frame: 24 hours
Results and safety
The study was stopped early. Results are not available in the source record.
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,prof study director
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 Sudden Cardiac Arrest and Seizures, 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: stopped early, 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 was stopped early. Results are not available in the source record.
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?
24 hours of EEG monitoring starting from resuscitation and quantity of non-convulsive status epilepticus found (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.