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Accuracy of EEG Slow Wave Activity in Predicting Favorable Outcome in Patients With Hypoxic Brain Injury—A Protocol for a Substudy of the STEPCARE Trial

Hästbacka, Johanna ; Westhall, Erik LU ; Moseby-Knappe, Marion LU ; Tiainen, Marjaana ; Lybeck, Anna LU orcid ; Reinikainen, Matti ; Levin, Helena LU ; Skrifvars, Markus B. ; Tirkkonen, Joonas and Jakobsen, Janus C. , et al. (2025) In Acta Anaesthesiologica Scandinavica 69(9).
Abstract

Background: Early restitution of electroencephalogram (EEG) slow wave activity (SWA) may be able to predict favorable functional outcome after cardiac arrest. SWA can be monitored using the C-Trend Index, a recently developed dynamic numerical index computed using commercially available medical device software. Methods: This is a pre-planned prospective substudy of the randomized controlled Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial. With a factorial design, the STEPCARE trial evaluates the effects of three different interventions (sedation, temperature management, and mean arterial blood pressure) on functional outcomes in adult out-of-hospital cardiac arrest (OHCA) patients. We will... (More)

Background: Early restitution of electroencephalogram (EEG) slow wave activity (SWA) may be able to predict favorable functional outcome after cardiac arrest. SWA can be monitored using the C-Trend Index, a recently developed dynamic numerical index computed using commercially available medical device software. Methods: This is a pre-planned prospective substudy of the randomized controlled Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial. With a factorial design, the STEPCARE trial evaluates the effects of three different interventions (sedation, temperature management, and mean arterial blood pressure) on functional outcomes in adult out-of-hospital cardiac arrest (OHCA) patients. We will record continuous EEG (cEEG) starting as early as possible after ICU admission. We will compare the accuracy (the proportion of correct predictions of all predictions) of C-Trend Index with that of blinded retrospective visual analysis of cEEG at 12 h after return of spontaneous circulation in predicting favorable functional outcome (modified Rankin Scale 0–3) 6 months after cardiac arrest. We aim to recruit 300 patients to show noninferiority in prognostic accuracy of the C-Trend Index compared with the visual analysis of cEEG, using a 2% limit for noninferiority. Furthermore, we will assess whether the therapeutic intervention related to sedation, carried out as a part of the STEPCARE trial modifies the performance of the EEG-based predictors. Conclusion: The study will compare the accuracy of SWA measured using C-Trend Index with the gold standard, visual analysis of cEEG, in predicting favorable functional outcome after OHCA. The study will also assess the effect of the sedation intervention of the STEPCARE trial on the predictive accuracy of C-Trend Index. If the accuracy of the C-Trend Index is non-inferior to the comparator's, it may provide a feasible and easy-to-learn bedside method, especially in hospitals with limited availability of neurophysiology expertise. Trial Registration: ClinicalTrials.gov identifier: NCT06564675.

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publication status
published
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in
Acta Anaesthesiologica Scandinavica
volume
69
issue
9
article number
e70126
publisher
Blackwell Munksgaard
external identifiers
  • pmid:40958738
  • scopus:105016355017
ISSN
0001-5172
DOI
10.1111/aas.70126
language
English
LU publication?
yes
id
45f2b08b-cb81-48e2-b3ff-f8daba8378c0
date added to LUP
2025-10-10 10:05:36
date last changed
2025-10-11 03:12:51
@article{45f2b08b-cb81-48e2-b3ff-f8daba8378c0,
  abstract     = {{<p>Background: Early restitution of electroencephalogram (EEG) slow wave activity (SWA) may be able to predict favorable functional outcome after cardiac arrest. SWA can be monitored using the C-Trend Index, a recently developed dynamic numerical index computed using commercially available medical device software. Methods: This is a pre-planned prospective substudy of the randomized controlled Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial. With a factorial design, the STEPCARE trial evaluates the effects of three different interventions (sedation, temperature management, and mean arterial blood pressure) on functional outcomes in adult out-of-hospital cardiac arrest (OHCA) patients. We will record continuous EEG (cEEG) starting as early as possible after ICU admission. We will compare the accuracy (the proportion of correct predictions of all predictions) of C-Trend Index with that of blinded retrospective visual analysis of cEEG at 12 h after return of spontaneous circulation in predicting favorable functional outcome (modified Rankin Scale 0–3) 6 months after cardiac arrest. We aim to recruit 300 patients to show noninferiority in prognostic accuracy of the C-Trend Index compared with the visual analysis of cEEG, using a 2% limit for noninferiority. Furthermore, we will assess whether the therapeutic intervention related to sedation, carried out as a part of the STEPCARE trial modifies the performance of the EEG-based predictors. Conclusion: The study will compare the accuracy of SWA measured using C-Trend Index with the gold standard, visual analysis of cEEG, in predicting favorable functional outcome after OHCA. The study will also assess the effect of the sedation intervention of the STEPCARE trial on the predictive accuracy of C-Trend Index. If the accuracy of the C-Trend Index is non-inferior to the comparator's, it may provide a feasible and easy-to-learn bedside method, especially in hospitals with limited availability of neurophysiology expertise. Trial Registration: ClinicalTrials.gov identifier: NCT06564675.</p>}},
  author       = {{Hästbacka, Johanna and Westhall, Erik and Moseby-Knappe, Marion and Tiainen, Marjaana and Lybeck, Anna and Reinikainen, Matti and Levin, Helena and Skrifvars, Markus B. and Tirkkonen, Joonas and Jakobsen, Janus C. and Nielsen, Niklas and Toppila, Jussi and Admiraal, Marjolein M. and Kortelainen, Jukka}},
  issn         = {{0001-5172}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{Blackwell Munksgaard}},
  series       = {{Acta Anaesthesiologica Scandinavica}},
  title        = {{Accuracy of EEG Slow Wave Activity in Predicting Favorable Outcome in Patients With Hypoxic Brain Injury—A Protocol for a Substudy of the STEPCARE Trial}},
  url          = {{http://dx.doi.org/10.1111/aas.70126}},
  doi          = {{10.1111/aas.70126}},
  volume       = {{69}},
  year         = {{2025}},
}