Frontal EEG in OHCA Feasibility Study (FEICA)

November 18, 2025 updated by: Medical University of Graz

Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study

This study aims to optimize the treatment of out-of-hospital cardiac arrest (OHCA) by focusing on neurological outcomes through Bispectral Index (BIS) monitoring. It will evaluate the feasibility of BIS monitoring in the prehospital phase, assess the need for sedation based on BIS values, and examine the timing of interventions in ICU (intensive care unit) settings to identify irreversible Hypoxic-Ischemic Brain Injury (HIBI).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The research project is designed to contribute to the low survival discharge rates of OHCA patients in Europe, which is currently around 8%.

Objectives:

  1. To assess the feasibility of BIS monitoring in the prehospital environment during CPR and ROSC.
  2. To determine the optimal mean BIS cut-off value after ROSC (Return of Spontaneous Circulation) during the prehospital phase.
  3. To assess BIS and etCO2 values in OHCA patients under evaluation of CPR quality.
  4. To understand the sedation needs based on BIS values.
  5. To identify the timing of interventions in the ICU that signify irreversible HIBI.

Phases:

  • Phase 1: The initial focus is assessing BIS and etCO2 values in OHCA patients receiving CPR.
  • Phase 2: We will investigate whether patients with higher mean BIS values (>25) require earlier and more sedation than those with lower BIS values.
  • Phase 3: This phase will examine ICU interventions and their timing to ascertain which patients are at risk of suffering from irreversible HIBI.

Methodology:

The project will utilize prehospital and ICU settings for a multidisciplinary approach, integrating cardiological, neurological, and anesthesiological perspectives. A pilot phase of 5 patients will be conducted initially to fine-tune the protocol and address any technical issues with the equipment.

Timeline:

The study will span approximately 14 months, starting with patient recruitment, data collection, and analysis and ending with the publication of results.

This project aims to provide critical insights into the feasibility and effectiveness of BIS monitoring in improving neurological outcomes for OHCA patients.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Medical University Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Out-of-hospital cardiac arrest adult patients

Description

Inclusion Criteria:

  • Age ≥18 years
  • In out-of-hospital cardiac arrest (OHCA)

Exclusion Criteria:

  • BIS application non-possible (for example, due to massive facial trauma)
  • No ALS (Advanced Life Support) performed
  • Clear signs of death
  • Sustained ROSC (>5 minutes after CPR with signs of life) on the arrival of the emergency physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Out-of-hospital cardiac arrest adult patients
All patients aged ≥18 years and in out-of-hospital cardiac arrest (OHCA) on arrival at the physician response unit (PRU) in Graz, Austria + surroundings.
Device: BIS Monitor
No interventions will be administered, but in addition to the standard of care according to the Guidelines of the European Resuscitation Council 2021, a frontal EEG-monitoring (BIS), a CPRMeter and a FlowMeter will be installed. The study will be observational only; the readings of the BIS monitor will be blinded to the treating PRU team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of BIS prehospital via quality parameters.
Time Frame: From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.
To evaluate if frontal EEG (BIS) measurements are feasible and valid under CPR and at ROSC in the prehospital setting. The proportion of patients meeting the signal quality criteria in more than 75% of the measurement period (Signal quality index >75, Electromyogram <30) will be presented with a two-sided 95% confidence interval to assess the primary aim.
From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.
Feasibility of BIS prehospital via a questionnaire.
Time Frame: Prehospital phase, on average 60 minutes.
The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling.
Prehospital phase, on average 60 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of neurological outcome.
Time Frame: Prehospital phase, on average 60 minutes.
To find the optimal mean BIS cut-off after ROSC throughout the prehospital phase associated with higher CPC scores at 1 month after the event.
Prehospital phase, on average 60 minutes.
CPR quality
Time Frame: Prehospital phase, on average 30 minutes.
To assess the correlation of BIS and etCO2 values in OHCA patients receiving CPR under evaluation of CPR quality.
Prehospital phase, on average 30 minutes.
Sedation at ROSC
Time Frame: Prehospital phase, on average 30 minutes.
Patients with higher mean BIS values (>25) will require earlier and more sedation than patients with values below.
Prehospital phase, on average 30 minutes.
ICU care
Time Frame: ICU stay, on average 4 days.
To assess all timings of interventions on ICU indicating irreversible HIBI.
ICU stay, on average 4 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

April 23, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V2.7.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data will be made available on specific requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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