Study of EEG Slow Wave Activity to Predict Recovery After Out-of-Hospital Cardiac Arrest in Adults A Substudy Within the STEPCARE Trial Using the Brainstatus Device

What this Trial Is About

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.

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