Clinical trial NCT06072092: Frontal EEG in OHCA Feasibility Study
Official title: Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Out-Of-Hospital Cardiac Arrest
BIS
Keywords: OHCA
BIS
ROSC
prehospital
PRU
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-of-hospital cardiac arrest adult patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of BIS prehospital via quality parameters.
timeFrame: From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.
measure: Feasibility of BIS prehospital via a questionnaire.
timeFrame: Prehospital phase, on average 60 minutes.
Secondary outcomes:
measure: Prediction of neurological outcome.
timeFrame: Prehospital phase, on average 60 minutes.
measure: CPR quality
timeFrame: Prehospital phase, on average 30 minutes.
measure: Sedation at ROSC
timeFrame: Prehospital phase, on average 30 minutes.
measure: ICU care
timeFrame: ICU stay, on average 4 days.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
Study officials:
References:
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.
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.
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.
citation: 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.