Out-Of-Hospital Cardiac ArrestPROPEASTEPCARENCT06564675
Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
An observational study of Out-Of-Hospital Cardiac Arrest, run by University of Helsinki at 4 sites in 2 countries.
Trial summary
This is an observational substudy embedded in the STEPCARE Trial. The study involves EEG analysis, covered by the ethics approval of STEPCARE Trial. The investigators aim to compare the accuracy of a continuously measured algorithm-based EEG index, C-Trend Index, with retrospective visual analysis of continuous EEG in… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- C-Trend Index
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Aug 2023to 3 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients resuscitated from OHCA
Who may be able to join
- Age 18 years or older
- OHCA, with sustained ROSC
- Unconscious after ROSC
- No limitations to full life support
- Randomized to STEPCARE Trial in a participating center with Brainstatus device available
Who cannot join
- age <18
- Previously randomized to STEPCARE
- Trauma or hemorrhage as the reasons for arrest
- Suspected or confirmed intracerebral hemorrhage
- Allergy to adhesive material
- Damaged skin at the frontal-temporal are preventing electrode attachment
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Jukka Kortelainen, MD, PhD contact
4 sites in 2 countries
Finland3 sites, 3 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, 00290
Marjaana Tiainen, A/C professor, 4711, marjaana.tiainen@hus.fi
Markus Skrifvars, professor, 4711, markus.skrifvars@hus.fi
- Recruiting
Kuopio University Hospital
Kuopio
Matti Reinikainen, professor, matti.reinikainen@pshyvinvointialue.fi
- Recruiting
Tampere University Hospital
Tampere
Johanna Hästbacka, A/C prof, +358415058360, johanna.hastbacka@tuni.fi
Joonas Tirkkonen
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital
Lund
Marion Moseby-Knappe, MD, PhD, +4646172443, marion.moseby_knappe@med.lu.se
Erik Westhall, A/C professor, erik.westhall@med.lu.se
About this study
This is an observational substudy embedded in the STEPCARE Trial. The study involves EEG analysis, covered by the ethics approval of STEPCARE Trial. The investigators aim to compare the accuracy of a continuously measured algorithm-based EEG index, C-Trend Index, with retrospective visual analysis of continuous EEG in predicting favorable functional outcome in adult patients treated in intensive care units after out-of-hospital cardiac arrest. The primary hypothesis is that the accuracy of C-Trend Index has at least 10% better accuracy in predicting favorable outcome than the visual analysis of cEEG, when assessed early, 9-12 hours after return of spontaneous circulation (ROSC).
Read the detailed description
STEPCARE Trial (Clinical trials identifier:NCT05564754) includes adult out-of-hospital cardiac arrest (OHCA) patients, with sustained ROSC, who remain comatose after resuscitation. STEPCARE is a factorial Trial, where all participants are randomized regarding three different interventions (minimal or deep sedation, target mean arterial pressure 65mmHg or 85mmHg, temperature management with or without a device). Patients with suspected or confirmed intracerebral hemorrhage, trauma or hemorrhage as reasons of arrest, those previously randomized to STEPCARE and patients with allergy to adhesive material or skin injury in the frontal-temporal area will be excluded (the latter two specific to this substudy).
The investigators aim to assess whether a new, algorithm-based index derived from continuous EEG (cEEG) recording is superior to retrospective visual analysis of cEEG in predicting functional outcome after OHCA, assessed restrospectively from early phase recordings, using the best hour within the 9-12-hour time interval after ROSC.
The cEEG will be collected using a commercially available Brainstatus device in selected centers participating in the STEPCARE Trial. cEEG will be visible to clinical team in centers using cEEG in routine monitoring, but blinded for those who do not routinely monitor cEEG in OHCA patients. C-Trend Index is blinded to clinicians and researchers, and will be analyzed retrospectively, after the primary outcome has been collected of the last patient of this substudy.
The primary outcome of this substudy is the functional outcome 6 months after OHCA, defined as modified Rankin Scale score (dichotomized as favourable mRS 0-3, and unfavourable mRS 4-6), assessed by blinded outcome assessors.
The investigators will compare accuracy (with separate comparisons of sensitivity and specificity) of C-Trend Index 9-12 hours after ROSC with the visual assessment of cEEG. C-Trend Index above a predefined cut-off value 20 is defined as indicative of favorable outcome, while in the visual assessment continuous or nearly continuous normal-voltage background without abundant discharges is considered indicative of favorable outcome .
To demonstrate a 10% difference in the accuracy, a sample size of 271 patients is needed. To account for loss of patients due to early wake-up, loss of follow-up, and technical issues in recordings the investigators aim at recruiting 300 patients.
As secondary research questions the study will also assess:
- The predictive accuracy off C-Trend Index in predicting unfavorable functional outcome, compared with visual analysis of cEEG
- The predictive accuracy of C-Trend Index using cut-off values 50 and 80 at 9-12 hours from ROSC in predicting favorable and unfavorable functional outcome
- Whether the predictive ability or the optimal cut-off value of C-Trend Index in predicting favorable and unfavorable functional outcome is affected by the three different interventions of the STEPCARE study
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- C-Trend Index
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Trend IndexDiagnostic test
Also called visual assessment of cEEG
C-trend-Index is collected blinded from the patients using Brainstatus device. The device shows and collects also cEEG. These are analyzed retrospectively after all study patients have their 6-month follow-up data collected. The intervention does not affect clinical management or decision-making.
| Study group | Role | What they receive |
|---|---|---|
| OHCA patients | OHCA patients, randomized to STEPCARE Trial. The patients are recruiten to this substudy in selected centers with access to the Brainstatus device for recording of cEEG.
Adult patients who remain comatose after sustained ROSC after OHCA are eligible to the STEPCARE Trial. Exclusion criteria are pregnancy, previous randomization to STEPCARE, trauma or hemorrhage as reasons for arrest, suspected or confirmed intracranial hemorrhage, and specifically for this study allergy to adhesive material and injured skin in the frontal-temporal area, that prevents adhesion of the Brainstatus electrode. Receives: Diagnostic Test: C-Trend Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive accuracy of C-Trend Index >20 for favorable functional outcome
Predictive accuracy of C-Trend Index >20 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting favourable functional outcome defined as modified Rankin Scale 0-3 six months after OHCA
Measured: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Secondary outcomes (4)
Predictive accuracy of C-Trend Index for unfavorable functional outcome
Predictive accuracy of C-Trend Index >20 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting unfavorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA
Measured: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Predictive accuracy of C-Trend Index >50 and >80 for favorable functional outcome
Predictive accuracy of C-Trend Index >50 and >80 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting favorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA
Measured: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Predictive accuracy of C-Trend Index >50 and >80 for unfavorable functional outcome
Predictive accuracy of C-Trend Index >50 and >80 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting unfavorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA
Measured: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Do the interventions in the STEPCARE Trial affect the predictive accuracy of C-trend Index
Is the predictive ability or the optimal cut-off values of C-Trend Index in predicting favourable and unfavourable outcomes affected by the three different interventions of the STEPCARE study
Measured: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Aug 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Skane University Hospital, Helsinki University Central Hospital, Kuopio University Hospital, Tampere University, Charite University, Berlin, Germany, Oslo University Hospital, Tampere University Hospital
- Responsible party
- Principal investigator, Johanna Hastbacka, Tampere University
- Investigators
- Jukka Kortelainen, MD, PhD, Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564675
- Sponsor's protocol ID
- STEPCARE-EEG
- Acronym
- PROPEASTEPCARE
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hastbacka J, Westhall E, Moseby-Knappe M, Tiainen M, Lybeck A, Reinikainen M, Levin H, Skrifvars MB, Tirkkonen J, Jakobsen JC, Nielsen N, Toppila J, Admiraal MM, Kortelainen J. Accuracy of EEG Slow Wave Activity in Predicting Favorable Outcome in Patients With Hypoxic Brain Injury-A Protocol for a Substudy of the STEPCARE Trial. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70126. doi: 10.1111/aas.70126.
PubMed 40958738
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
- ClinicalTrials.gov ID
- NCT06564675
- Acronym / sponsor ID
- PROPEASTEPCARE / STEPCARE-EEG
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- University of Oulu, Skane University Hospital, Helsinki University Central Hospital, Kuopio University Hospital, Tampere University, Charite University, Berlin, Germany, Oslo University Hospital, Tampere University Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- 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.
This is an observational substudy embedded in the STEPCARE Trial. The study involves EEG analysis, covered by the ethics approval of STEPCARE Trial. The investigators aim to compare the accuracy of a continuously measured algorithm-based EEG index, C-Trend Index, with retrospective visual analysis of continuous EEG in predicting favorable functional outcome in adult patients treated in intensive care units after out-of-hospital cardiac arrest. The primary hypothesis is that the accuracy of C-Trend Index has at least 10% better accuracy in predicting favorable outcome than the visual analysis of cEEG, when assessed early, 9-12 hours after return of spontaneous circulation (ROSC).
Detailed description
STEPCARE Trial (Clinical trials identifier:NCT05564754) includes adult out-of-hospital cardiac arrest (OHCA) patients, with sustained ROSC, who remain comatose after resuscitation. STEPCARE is a factorial Trial, where all participants are randomized regarding three different interventions (minimal or deep sedation, target mean arterial pressure 65mmHg or 85mmHg, temperature management with or without a device). Patients with suspected or confirmed intracerebral hemorrhage, trauma or hemorrhage as reasons of arrest, those previously randomized to STEPCARE and patients with allergy to adhesive material or skin injury in the frontal-temporal area will be excluded (the latter two specific to this substudy).
The investigators aim to assess whether a new, algorithm-based index derived from continuous EEG (cEEG) recording is superior to retrospective visual analysis of cEEG in predicting functional outcome after OHCA, assessed restrospectively from early phase recordings, using the best hour within the 9-12-hour time interval after ROSC.
The cEEG will be collected using a commercially available Brainstatus device in selected centers participating in the STEPCARE Trial. cEEG will be visible to clinical team in centers using cEEG in routine monitoring, but blinded for those who do not routinely monitor cEEG in OHCA patients. C-Trend Index is blinded to clinicians and researchers, and will be analyzed retrospectively, after the primary outcome has been collected of the last patient of this substudy.
The primary outcome of this substudy is the functional outcome 6 months after OHCA, defined as modified Rankin Scale score (dichotomized as favourable mRS 0-3, and unfavourable mRS 4-6), assessed by blinded outcome assessors.
The investigators will compare accuracy (with separate comparisons of sensitivity and specificity) of C-Trend Index 9-12 hours after ROSC with the visual assessment of cEEG. C-Trend Index above a predefined cut-off value 20 is defined as indicative of favorable outcome, while in the visual assessment continuous or nearly continuous normal-voltage background without abundant discharges is considered indicative of favorable outcome .
To demonstrate a 10% difference in the accuracy, a sample size of 271 patients is needed. To account for loss of patients due to early wake-up, loss of follow-up, and technical issues in recordings the investigators aim at recruiting 300 patients.
As secondary research questions the study will also assess:
- The predictive accuracy off C-Trend Index in predicting unfavorable functional outcome, compared with visual analysis of cEEG
- The predictive accuracy of C-Trend Index using cut-off values 50 and 80 at 9-12 hours from ROSC in predicting favorable and unfavorable functional outcome
- Whether the predictive ability or the optimal cut-off value of C-Trend Index in predicting favorable and unfavorable functional outcome is affected by the three different interventions of the STEPCARE study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA patients | – | Diagnostic Test: C-Trend IndexOHCA patients, randomized to STEPCARE Trial. The patients are recruiten to this substudy in selected centers with access to the Brainstatus device for recording of cEEG. Adult patients who remain comatose after sustained ROSC after OHCA are eligible to the STEPCARE Trial. Exclusion criteria are pregnancy, previous randomization to STEPCARE, trauma or hemorrhage as reasons for arrest, suspected or confirmed intracranial hemorrhage, and specifically for this study allergy to adhesive material and injured skin in the frontal-temporal area, that prevents adhesion of the Brainstatus electrode. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients resuscitated from OHCA
Key inclusion criteria (5 listed)
- Age 18 years or older
- OHCA, with sustained ROSC
- Unconscious after ROSC
- No limitations to full life support
- Randomized to STEPCARE Trial in a participating center with Brainstatus device available
Key exclusion criteria (6 listed)
- age <18
- Previously randomized to STEPCARE
- Trauma or hemorrhage as the reasons for arrest
- Suspected or confirmed intracerebral hemorrhage
- Allergy to adhesive material
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 |
|---|---|---|
| C-Trend IndexAlso: visual assessment of cEEGC-trend-Index is collected blinded from the patients using Brainstatus device. The device shows and collects also cEEG. These are analyzed retrospectively after all study patients have their 6-month follow-up data collected. The intervention does not affect clinical management or decision-making. | Diagnostic test | OHCA patients |
Primary outcome
Predictive accuracy of C-Trend Index >20 for favorable functional outcome
Time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Predictive accuracy of C-Trend Index >20 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting favourable functional outcome defined as modified Rankin Scale 0-3 six months after OHCA
4 secondary outcomes
Predictive accuracy of C-Trend Index for unfavorable functional outcome
Time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Predictive accuracy of C-Trend Index >50 and >80 for favorable functional outcome
Time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Predictive accuracy of C-Trend Index >50 and >80 for unfavorable functional outcome
Time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Do the interventions in the STEPCARE Trial affect the predictive accuracy of C-trend Index
Time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Derived from this study: PubMed 40958738Hastbacka J, Westhall E, Moseby-Knappe M, Tiainen M, Lybeck A, Reinikainen M, Levin H, Skrifvars MB, Tirkkonen J, Jakobsen JC, Nielsen N, Toppila J, Admiraal MM, Kortelainen J. Accuracy of EEG Slow Wave Activity in Predicting Favorable Outcome in Patients With Hypoxic Brain Injury-A Protocol for a Substudy of the STEPCARE Trial. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70126. doi: 10.1111/aas.70126.
- Individual participant dataSharing planned: Undecided
Related trials for Out-Of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
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.
Jukka Kortelainen, MD, PhD contact
Jukka Kortelainen, MD, PhD study director
University of Oulu
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by University of Helsinki at 4 sites in 2 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Hästbacka, a/c professor (+358415058360, johanna.hastbacka@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive accuracy of C-Trend Index >20 for favorable functional outcome (time frame: cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564675, which also lists 1 linked publication.
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 28 Aug 2024.