Frontal EEG in OHCA Feasibility Study

NCT06072092 | Active Not Recruiting

• 1 other identifier: V2.7.1
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Out-Of-Hospital Cardiac Arrest; BIS

Keywords

OHCA; BIS; ROSC; prehospital; PRU

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Prediction of neurological outcome.

  Prehospital phase, on average 60 minutes.

• CPR quality

  Prehospital phase, on average 30 minutes.

• Sedation at ROSC

  Prehospital phase, on average 30 minutes.

• ICU care

  ICU stay, on average 4 days.

Study Arms (1)

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

Interventions

BIS Monitor DEVICE

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.

Out-of-hospital cardiac arrest adult patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Out-of-hospital cardiac arrest adult patients

You may qualify if:

• Age ≥18 years
• In out-of-hospital cardiac arrest (OHCA)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Related Publications (5)

• 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.

  PMID: 32027980 BACKGROUND

• 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.

  PMID: 36762679 BACKGROUND

• 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.

  PMID: 32365854 BACKGROUND

• 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.

  PMID: 35570124 BACKGROUND

• Eichinger M, Zoidl P, Reisinger AC, Orlob S, Hatzl S, Eichlseder M, Pichler A, Eberl A, Kuenzer T, Zajic P, Heuschneider L, Honnef G, Rief M, Bornemann-Cimenti H. Assessment of frontal EEG measurement in out-of-hospital cardiac arrest: a prospective observational feasibility study - study protocol. BMJ Open. 2025 Feb 26;15(2):e094258. doi: 10.1136/bmjopen-2024-094258.

  PMID: 40010837 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-04

Locations

AU (1)