Frontal EEG in OHCA Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Out-Of-Hospital Cardiac Arrest, BIS

Intervention / Treatment
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* Device: BIS Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Out-of-hospital cardiac arrest adult patients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of BIS prehospital via quality parameters. | 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. | From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes. | 
| Feasibility of BIS prehospital via a questionnaire. | The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling. | Prehospital phase, on average 60 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of neurological outcome. | 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. | Prehospital phase, on average 60 minutes. | 
| CPR quality | To assess the correlation of BIS and etCO2 values in OHCA patients receiving CPR under evaluation of CPR quality. | Prehospital phase, on average 30 minutes. | 
| Sedation at ROSC | Patients with higher mean BIS values (>25) will require earlier and more sedation than patients with values below. | Prehospital phase, on average 30 minutes. | 
| ICU care | To assess all timings of interventions on ICU indicating irreversible HIBI. | ICU stay, on average 4 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BIS, OHCA, ROSC, prehospital, PRU