FEICA: Frontal EEG in OHCA Feasibility Study

Sponsor

Medical University of Graz (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06072092

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest BIS	Device: BIS Monitor

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:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

45 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Feasibility of BIS prehospital via quality parameters. [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.
Feasibility of BIS prehospital via a questionnaire. [Prehospital phase, on average 60 minutes.]
The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling.

Secondary Outcome Measures

Prediction of neurological outcome. [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.
CPR quality [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.
Sedation at ROSC [Prehospital phase, on average 30 minutes.]
Patients with higher mean BIS values (>25) will require earlier and more sedation than patients with values below.
ICU care [ICU stay, on average 4 days.]
To assess all timings of interventions on ICU indicating irreversible HIBI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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