Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06072092

Frontal EEG in OHCA 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Out-Of-Hospital Cardiac Arrest BIS Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz

Graz, Styria, 8036, Austria

About this study

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

Objectives:

  • To assess the feasibility of BIS monitoring in the prehospital environment during CPR and ROSC.
  • To determine the optimal mean BIS cut-off value after ROSC (Return of Spontaneous Circulation) during the prehospital phase.
  • To assess BIS and etCO2 values in OHCA patients under evaluation of CPR quality.
  • To understand the sedation needs based on BIS values.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS monitor

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. ICU care

    Time frame: ICU stay, on average 4 days.

    To assess all timings of interventions on ICU indicating irreversible HIBI.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: FEICA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.