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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorUniversity of Helsinki

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

OHCA, with sustained ROSC

Unconscious after ROSC

No limitations to full life support

Disqualifiers

age <18

Previously randomized to STEPCARE

Trauma or hemorrhage as the reasons for arrest

Suspected or confirmed intracerebral hemorrhage

Trial population

Adults patients resuscitated from OHCA

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • C-Trend Index

    Diagnostic test

    C-trend-Index is collected blinded from the patients using Brainstatus device. The device shows and collects also cEEG. These are analyzed retrospectively after all study patients have their 6-month follow-up data collected. The intervention does not affect clinical management or decision-making.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: OHCA patients1 intervention

Trial outcomes

Primary outcomes

1

Predictive accuracy of C-Trend Index >20 for favorable functional outcome

Predictive accuracy of C-Trend Index \>20 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting favourable functional outcome defined as modified Rankin Scale 0-3 six months after OHCA

Time frame
cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.

Secondary outcomes

1

Predictive accuracy of C-Trend Index for unfavorable functional outcome

Predictive accuracy of C-Trend Index \>20 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting unfavorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA

Time frame
cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
2

Predictive accuracy of C-Trend Index >50 and >80 for favorable functional outcome

Predictive accuracy of C-Trend Index \>50 and \>80 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting favorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA

Time frame
cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
3

Predictive accuracy of C-Trend Index >50 and >80 for unfavorable functional outcome

Predictive accuracy of C-Trend Index \>50 and \>80 at 9-12 hours from ROSC compared to retrospective visual analysis of cEEG in predicting unfavorable functional outcome defined as modified Rankin Scale 4-6 six months after OHCA

Time frame
cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.
4

Do the interventions in the STEPCARE Trial affect the predictive accuracy of C-trend Index

Is the predictive ability or the optimal cut-off values of C-Trend Index in predicting favourable and unfavourable outcomes affected by the three different interventions of the STEPCARE study

Time frame
cEEG is recorded at least 24 hours after inclusion to the study, or until the patient awakens to respond to verbal commands. Data collected from recorded cEEG and C-Trend Index are assessed from the time point of 9-12 hours from ROSC.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Helsinki

Lead sponsor

Tampere University

Sponsor institution

University of Oulu

Collaborator

Skane University Hospital

Collaborator

Helsinki University Central Hospital

Collaborator

Kuopio University Hospital

Collaborator

Tampere University

Collaborator

Charite University, Berlin, Germany

Collaborator

Oslo University Hospital

Collaborator

Tampere University Hospital

Collaborator