About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
OHCA, with sustained ROSC
Unconscious after ROSC
No limitations to full life support
Disqualifiers
age <18
Previously randomized to STEPCARE
Trauma or hemorrhage as the reasons for arrest
Suspected or confirmed intracerebral hemorrhage
Trial population
Adults patients resuscitated from OHCA
Trial design
Cohort
Prospective
Treatments tested in this trial
C-Trend Index
Diagnostic testC-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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Helsinki
Lead sponsor
Tampere University
Sponsor institution
University of Oulu
Collaborator
Skane University Hospital
Collaborator
Helsinki University Central Hospital
Collaborator
Kuopio University Hospital
Collaborator
Tampere University
Collaborator
Charite University, Berlin, Germany
Collaborator
Oslo University Hospital
Collaborator
Tampere University Hospital
Collaborator