Frontal EEG in OHCA Feasibility Study

Active, not recruiting

• Conditions: Out-Of-Hospital Cardiac Arrest; BIS
• Interventions: Device: BIS Monitor

• Registration Number: NCT06072092
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Study Start: 2024-01-01
• Status Verified: 2025-04
• Primary Completion: 2025-04-23
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Out-of-hospital cardiac arrest adult patients	BIS Monitor	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Medical University Graz; 🇦🇹 Graz, Styria, Austria