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RECRUITING
NCT06564675

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

Sponsor: University of Helsinki

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 110 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2023-08-01

Completion Date

2027-03-03

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

C-Trend Index

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)

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Tampere University Hospital

Tampere, Finland

Skane University Hospital

Lund, Sweden