Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
University of Helsinki
300 participants
Aug 1, 2023
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria6
- 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
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Interventions
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06564675