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

NCT ID: NCT06564675

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2027-03-03

Brief Summary

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).

Detailed Description

STEPCARE Trial (Clinical trials identifier:NCT05564754) includes adult out-of-hospital cardiac arrest (OHCA) patients, with sustained ROSC, who remain comatose after resuscitation. STEPCARE is a factorial Trial, where all participants are randomized regarding three different interventions (minimal or deep sedation, target mean arterial pressure 65mmHg or 85mmHg, temperature management with or without a device). Patients with suspected or confirmed intracerebral hemorrhage, trauma or hemorrhage as reasons of arrest, those previously randomized to STEPCARE and patients with allergy to adhesive material or skin injury in the frontal-temporal area will be excluded (the latter two specific to this substudy).

The investigators aim to assess whether a new, algorithm-based index derived from continuous EEG (cEEG) recording is superior to retrospective visual analysis of cEEG in predicting functional outcome after OHCA, assessed restrospectively from early phase recordings, using the best hour within the 9-12-hour time interval after ROSC.

The cEEG will be collected using a commercially available Brainstatus device in selected centers participating in the STEPCARE Trial. cEEG will be visible to clinical team in centers using cEEG in routine monitoring, but blinded for those who do not routinely monitor cEEG in OHCA patients. C-Trend Index is blinded to clinicians and researchers, and will be analyzed retrospectively, after the primary outcome has been collected of the last patient of this substudy.

The primary outcome of this substudy is the functional outcome 6 months after OHCA, defined as modified Rankin Scale score (dichotomized as favourable mRS 0-3, and unfavourable mRS 4-6), assessed by blinded outcome assessors.

The investigators will compare accuracy (with separate comparisons of sensitivity and specificity) of C-Trend Index 9-12 hours after ROSC with the visual assessment of cEEG. C-Trend Index above a predefined cut-off value 20 is defined as indicative of favorable outcome, while in the visual assessment continuous or nearly continuous normal-voltage background without abundant discharges is considered indicative of favorable outcome .

To demonstrate a 10% difference in the accuracy, a sample size of 271 patients is needed. To account for loss of patients due to early wake-up, loss of follow-up, and technical issues in recordings the investigators aim at recruiting 300 patients.

As secondary research questions the study will also assess:

• The predictive accuracy off C-Trend Index in predicting unfavorable functional outcome, compared with visual analysis of cEEG
• The predictive accuracy of C-Trend Index using cut-off values 50 and 80 at 9-12 hours from ROSC in predicting favorable and unfavorable functional outcome
• Whether the predictive ability or the optimal cut-off value of C-Trend Index in predicting favorable and unfavorable functional outcome is affected by the three different interventions of the STEPCARE study

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OHCA patients

OHCA patients, randomized to STEPCARE Trial. The patients are recruiten to this substudy in selected centers with access to the Brainstatus device for recording of cEEG.

Adult patients who remain comatose after sustained ROSC after OHCA are eligible to the STEPCARE Trial. Exclusion criteria are pregnancy, previous randomization to STEPCARE, trauma or hemorrhage as reasons for arrest, suspected or confirmed intracranial hemorrhage, and specifically for this study allergy to adhesive material and injured skin in the frontal-temporal area, that prevents adhesion of the Brainstatus electrode.

C-Trend Index

Intervention Type: 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.

Interventions

C-Trend Index

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

visual assessment of cEEG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: collaborator

Skane University Hospital

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Tampere University Hospital

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Johanna Hastbacka

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jukka Kortelainen, MD, PhD

Role: STUDY_DIRECTOR

University of Oulu

Locations

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status: RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Skane University Hospital

Lund, , Sweden

Site Status: RECRUITING

Countries

Finland; Sweden

Central Contacts

Johanna Hästbacka, a/c professor

Role: CONTACT

johanna.hastbacka@tuni.fi

+358415058360

Jukka Kortelainen, MD, PhD

Role: CONTACT

jukka.kortelainen@oulu.fi

Facility Contacts

Marjaana Tiainen, A/C professor

Role: primary

marjaana.tiainen@hus.fi

4711

Markus Skrifvars, professor

Role: backup

markus.skrifvars@hus.fi

4711

Matti Reinikainen, professor

Role: primary

matti.reinikainen@pshyvinvointialue.fi

Johanna Hästbacka, A/C prof

Role: primary

johanna.hastbacka@tuni.fi

+358415058360

Marion Moseby-Knappe, MD, PhD

Role: primary

marion.moseby_knappe@med.lu.se

+4646172443

Erik Westhall, A/C professor

Role: backup

erik.westhall@med.lu.se

References

Hastbacka J, Westhall E, Moseby-Knappe M, Tiainen M, Lybeck A, Reinikainen M, Levin H, Skrifvars MB, Tirkkonen J, Jakobsen JC, Nielsen N, Toppila J, Admiraal MM, Kortelainen J. 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. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70126. doi: 10.1111/aas.70126.

Reference Type: DERIVED

PMID: 40958738 (View on PubMed)

Other Identifiers

STEPCARE-EEG

Identifier Type: -

Identifier Source: org_study_id