Actively Recruiting
Led by University of Helsinki · Updated on 2024-08-28
300
Participants Needed
4
Research Sites
26 weeks
Total Duration
U
University of Helsinki
Lead Sponsor
U
University of Oulu
Collaborating Sponsor
Researchers are studying adult patients who have experienced out-of-hospital cardiac arrest (OHCA) and remain unconscious after resuscitation. This observational substudy, part of the larger STEPCARE Trial, aims to compare a new algorithm-based EEG index called the C-Trend Index with traditional visual analysis of continuous EEG (cEEG) recordings. The goal is to see which method better predicts patients' functional outcomes six months after the cardiac arrest, focusing on early EEG data collected 9 to 12 hours after the return of spontaneous circulation (ROSC). Participants are adults who have had OHCA and sustained ROSC but remain comatose. They are enrolled in the STEPCARE Trial and monitored using the Brainstatus device to collect cEEG data. The C-Trend Index is recorded continuously and analyzed retrospectively without affecting patient care or clinical decisions. The study compares the predictive accuracy of the C-Trend Index and visual EEG analysis, assessing favorable outcomes defined by a modified Rankin Scale score. Secondary aims include evaluating different cut-off values of the index and how other STEPCARE Trial interventions may influence its accuracy. During the study, EEG data is collected at least 24 hours after inclusion or until the patient awakens. Researchers assess the EEG recordings from the 9-12 hour window after ROSC to measure the primary outcome of functional status six months later. The study involves monitoring and analysis of EEG patterns and the C-Trend Index, with blinded outcome assessors evaluating patient recovery. The study plans to enroll around 300 patients to ensure enough data, accounting for potential early recovery or data loss.
CONDITIONS
Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 24 hours or until awakening
Participants are monitored with continuous EEG (cEEG) recording using the Brainstatus device to collect data on brain activity after cardiac arrest. The EEG data is collected for at least 24 hours after inclusion or until the participant awakens to respond to verbal commands. The C-Trend Index is derived from this recording but is analyzed retrospectively, without affecting clinical care.
Continuous monitoring during this period
Duration - 6 months after cardiac arrest
Participants' functional outcomes are assessed 6 months after cardiac arrest to evaluate recovery and the predictive accuracy of EEG data collected earlier in the trial.
1 follow-up visit for outcome assessment
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
J
Johanna Hästbacka, a/c professor
J
Jukka Kortelainen, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Johanna Hästbacka, Erik Westhall, Marion Moseby-Knappe...
https://pubmed.ncbi.nlm.nih.gov/40958738