Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
NCT Number: NCT06564675
Acronym: PROPEASTEPCARE
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Out-Of-Hospital Cardiac Arrest
Interventions: DIAGNOSTIC_TEST: C-Trend Index
Sponsor: University of Helsinki
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
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2023-08-01
Completion Date: 2027-03-03
Locations: Helsinki University Hospital, Helsinki, 00290, Finland|Kuopio University Hospital, Kuopio, Finland|Tampere University Hospital, Tampere, Finland|Skane University Hospital, Lund, Sweden

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 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).

Primary Outcome Measures: 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, 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 Outcome Measures: 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, 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, 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, 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, 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.