Using EEG to predict outcomes in patients with brain injury after cardiac arrest
Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial
This study is testing if a new way of analyzing brain waves can better predict recovery in adults who have survived a cardiac arrest compared to the usual method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University of Helsinki Academic / other |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT06564675 on ClinicalTrials.gov |
What this trial studies
This observational substudy, part of the STEPCARE Trial, focuses on analyzing EEG data to predict favorable outcomes in adult patients who have experienced out-of-hospital cardiac arrest and have returned to spontaneous circulation. The study compares a new algorithm-based EEG index, the C-Trend Index, with traditional visual analysis of continuous EEG to determine which method more accurately predicts patient recovery. EEG recordings will be collected using a Brainstatus device, and the analysis will be conducted retrospectively, focusing on data collected 9-12 hours after resuscitation. The goal is to establish whether the C-Trend Index can provide at least a 10% improvement in predictive accuracy over visual analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced out-of-hospital cardiac arrest and remain unconscious after resuscitation.
Not a fit: Patients under 18, those with trauma or hemorrhage as the cause of arrest, or those with skin issues preventing electrode attachment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict recovery outcomes in patients after cardiac arrest, leading to better-informed treatment decisions.
How similar studies have performed: While this approach is novel in its specific application, similar studies using EEG for outcome prediction in cardiac arrest patients have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * age \<18 * Previously randomized to STEPCARE * Trauma or hemorrhage as the reasons for arrest * Suspected or confirmed intracerebral hemorrhage * Allergy to adhesive material * Damaged skin at the frontal-temporal are preventing electrode attachment
Where this trial is running
Helsinki and 3 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Skane University Hospital — Lund, Sweden (Recruiting)
Study contacts
- Study coordinator: Johanna Hästbacka, a/c professor
- Email: johanna.hastbacka@tuni.fi
- Phone: +358415058360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.