Actively Recruiting

Age: 18Years - 110Years
All Genders
NCT06564675

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

Led by University of Helsinki · Updated on 2024-08-28

300

Participants Needed

4

Research Sites

187 weeks

Total Duration

On this page

Sponsors

U

University of Helsinki

Lead Sponsor

U

University of Oulu

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Out-of-hospital cardiac arrest (OHCA) with sustained return of spontaneous circulation (ROSC)
  • Unconscious after ROSC
  • No limitations to full life support
  • Randomized to STEPCARE Trial in a participating center with Brainstatus device available
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Previously randomized to STEPCARE Trial
  • Trauma or hemorrhage as the cause of cardiac arrest
  • Suspected or confirmed intracerebral hemorrhage
  • Allergy to adhesive material
  • Damaged skin at the frontal-temporal area preventing electrode attachment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Helsinki University Hospital

Helsinki, Finland, 00290

Actively Recruiting

2

Kuopio University Hospital

Kuopio, Finland

Actively Recruiting

3

Tampere University Hospital

Tampere, Finland

Actively Recruiting

4

Skane University Hospital

Lund, Sweden

Actively Recruiting

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Research Team

J

Johanna Hästbacka, a/c professor

CONTACT

J

Jukka Kortelainen, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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