Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-11 @ 7:35 PM
Study NCT ID:
NCT06072092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frontal EEG in OHCA Feasibility Study
Sponsor:
Medical University of Graz
Organization:
Study Overview
Official Title:
Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEICA
Brief 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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: