Cardiac ArrestNCT02344693
Electroencephalography in Patients Resuscitated From Cardiac Arrest
An observational study of Cardiac Arrest and Heart Arrest, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Heart Arrest
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2017to Dec 2019
- How long will I take part?
- 1 Month
- 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: Patients resuscitated from a non-traumatic cardiac arrest in a urban setting in southern Finland
Who may be able to join
- Witnessed Cardiac Arrest
- Return of spontaneous circulation following cardiac arrest 10-40 min
Who cannot join
- traumatic cardiac arrest
- no consent from next-of-kin
Trial locations and contacts
1 site in 1 country.
Johannes Björkman, MD contact
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki, 00029
Johannes Björkman, johannes.bjorkman@helsinki.fi
Johannes Björkman, MD
About this study
Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.
- Conditions
- Cardiac Arrest, Heart Arrest
- Keywords
- Electroencephalography
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
prehospital EEG value in regard to patient discharge
Measured: 60-min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start1 Aug 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Björkman, Helsinki University Central Hospital
- Investigators
- Johannes Björkman, MD, Principal investigator, Helsinki University Central HospitalTom Silfvast, MD, PhD, Study director, Helsinki University Central HospitalTapani Salmi, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344693
- Sponsor's protocol ID
- 237/4 03.12.2012
- Status last verified
- Jun 2018
- First submitted
- 16 Jan 2015
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalography in Patients Resuscitated From Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02344693
- Acronym / sponsor ID
- 237/4 03.12.2012
- Conditions
- Cardiac Arrest, Heart Arrest
- Keywords
- Electroencephalography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 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.
Sudden cardiac death can occur due to a multitude of causes. The underlying case can affect the overall prognosis. A return of spontaneous circulation not exceeding 30 minutes following a successful cardiopulmonary resuscitation is usually deemed imperative, if the patient is to survive. Monitors for evaluating the cardiac function during and after resuscitation are implemented on a daily basis (ekg, pulseoxymetry, blood pressure monitoring, cardiac sonography), but no devices for registration of the cortical brain activity exist. The aim of this study is to provide a 3-channel electroencephalogram using a prototype EEG/EKG adapter, connected to a Physio-Control LifePak 15 monitor/defibrillator, in patients who regain spontaneous circulation following non-traumatic cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients resuscitated from a non-traumatic cardiac arrest in a urban setting in southern Finland
Key inclusion criteria (2 listed)
- Witnessed Cardiac Arrest
- Return of spontaneous circulation following cardiac arrest 10-40 min
Key exclusion criteria (2 listed)
- traumatic cardiac arrest
- no consent from next-of-kin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prehospital EEG value in regard to patient discharge
Time frame: 60-min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
Johannes Björkman, MD contact
Johannes Björkman, MD principal investigator
Helsinki University Central Hospital
Tom Silfvast, MD, PhD study director
Helsinki University Central Hospital
Tapani Salmi, MD, PhD study director
Helsinki University Central Hospital
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 Cardiac Arrest and Heart Arrest, run by Helsinki University Central 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 2 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: status not confirmed, as of the sponsor's last update on 21 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Björkman, MD (johannes.bjorkman@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prehospital EEG value in regard to patient discharge (time frame: 60-min). 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 21 Jun 2018.