Frontal EEG in OHCA Feasibility Study

Out-Of-Hospital Cardiac Arrest Clinical Trial

— FEICA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06072092
• Other study ID #: V2.7
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: Michael Eichinger, MD, MSc
• Phone: +43316385
• Email: michael.eichinger[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 1, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (4)

Arbas-Redondo E, Rosillo-Rodriguez SO, Merino-Argos C, Marco-Clement I, Rodriguez-Sotelo L, Martinez-Marin LA, Martin-Polo L, Velez-Salas A, Caro-Codon J, Garcia-Arribas D, Armada-Romero E, Lopez-De-Sa E. Bispectral index and suppression ratio after cardiac arrest: are they useful as bedside tools for rational treatment escalation plans? Rev Esp Cardiol (Engl Ed). 2022 Dec;75(12):992-1000. doi: 10.1016/j.rec.2022.03.004. Epub 2022 May 12. English, Spanish. — View Citation

Chang CY, Chen CS, Chien YJ, Lin PC, Wu MY. The Effects of Early Bispectral Index to Predict Poor Neurological Function in Cardiac Arrest Patients: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2020 Apr 30;10(5):271. doi: 10.3390/diagnostics10050271. — View Citation

Grasner JT, Wnent J, Herlitz J, Perkins GD, Lefering R, Tjelmeland I, Koster RW, Masterson S, Rossell-Ortiz F, Maurer H, Bottiger BW, Moertl M, Mols P, Alihodzic H, Hadzibegovic I, Ioannides M, Truhlar A, Wissenberg M, Salo A, Escutnaire J, Nikolaou N, Nagy E, Jonsson BS, Wright P, Semeraro F, Clarens C, Beesems S, Cebula G, Correia VH, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Booth S, Bossaert L. Survival after out-of-hospital cardiac arrest in Europe - Results of the EuReCa TWO study. Resuscitation. 2020 Mar 1;148:218-226. doi: 10.1016/j.resuscitation.2019.12.042. Epub 2020 Feb 3. — View Citation

Sandroni C, Skrifvars MB, Taccone FS. Brain monitoring after cardiac arrest. Curr Opin Crit Care. 2023 Apr 1;29(2):68-74. doi: 10.1097/MCC.0000000000001023. Epub 2023 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	ICU care	To assess all timings of interventions on ICU indicating irreversible HIBI.	ICU stay, on average 4 days.