Frontal EEG in OHCA Feasibility Study (FEICA)

Medical University of Graz

Status: Active, not recruiting

Conditions: Out-Of-Hospital Cardiac Arrest; BIS

Treatments: Device: BIS Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT06072092

V2.7.1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Out-of-hospital cardiac arrest adult patients

Description:

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.

Treatment:

Device: BIS Monitor