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

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).

Conditions

• Out-Of-Hospital Cardiac Arrest

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.

Sponsors & Collaborators

• University of Oulu

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Tampere University

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• University of Helsinki

  lead OTHER

Principal Investigators

• Jukka Kortelainen, MD, PhD · University of Oulu

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2026-08-31

Completion

2027-03-03

Countries

• Finland
• Sweden

Study Locations