Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
Recruiting now
Conditions studied: Out-Of-Hospital Cardiac Arrest
In brief
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).
Key facts
- Study ID
- NCT06564675
- Run by
- University of Helsinki
- People needed
- 300
- Starts
- 2023-08-01
- Expected to finish
- 2027-03-03
- Last updated by the study team
- 2024-08-28
Who can join
Age: 18 and older, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Helsinki University Hospital — Helsinki, Finland (enrolling)
- Kuopio University Hospital — Kuopio, Finland (enrolling)
- Tampere University Hospital — Tampere, Finland (enrolling)
- Skane University Hospital — Lund, Sweden (enrolling)
Full record on ClinicalTrials.gov
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