Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorUniversity of Helsinki

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

Qualifiers

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 design

Treatments tested in this trial

  • C-Trend Index

Treatment groups

300 Participants
are divided into 1 treatment group

Sponsors and collaborators

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