Frontal EEG in OHCA Feasibility Study

Status Recruiting

Clinical Trial Summary

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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06072092
Study type	Observational
Source	Medical University of Graz
Contact	Michael Eichinger, MD, MSc
Phone	+43316385
Email	michael.eichinger@medunigraz.at
Status	Recruiting
Phase
Start date	January 1, 2024
Completion date	April 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Frontal EEG in OHCA Feasibility Study — FEICA

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms