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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
RECRUITING
Kuopio
Tampere University Hospital
RECRUITING
Tampere
Sweden
Skane University Hospital
RECRUITING
Lund
Contact Information
Primary
Johanna Hästbacka, a/c professor
johanna.hastbacka@tuni.fi
+358415058360
Backup
Jukka Kortelainen, MD, PhD
jukka.kortelainen@oulu.fi
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2027-03-03
Participants
Target number of participants: 300
Treatments
OHCA patients
OHCA patients, randomized to STEPCARE Trial. The patients are recruiten to this substudy in selected centers with access to the Brainstatus device for recording of cEEG.~Adult patients who remain comatose after sustained ROSC after OHCA are eligible to the STEPCARE Trial. Exclusion criteria are pregnancy, previous randomization to STEPCARE, trauma or hemorrhage as reasons for arrest, suspected or confirmed intracranial hemorrhage, and specifically for this study allergy to adhesive material and injured skin in the frontal-temporal area, that prevents adhesion of the Brainstatus electrode.
Related Therapeutic Areas
Sponsors
Collaborators: Tampere University Hospital, Charite University, Berlin, Germany, Oslo University Hospital, Helsinki University Central Hospital, Tampere University, University of Oulu, Skane University Hospital, Kuopio University Hospital
Leads: University of Helsinki

This content was sourced from clinicaltrials.gov