Out-Of-Hospital Cardiac ArrestFEICANCT06072092
Frontal EEG in OHCA Feasibility Study
An observational study of Out-Of-Hospital Cardiac Arrest and BIS, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, BIS
- What is being tested?
- BIS Monitor
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Out-of-hospital cardiac arrest adult patients
Who may be able to join
- Age ≥18 years
- In out-of-hospital cardiac arrest (OHCA)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study
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).
Read the 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:
- 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.
- Conditions
- Out-Of-Hospital Cardiac Arrest, BIS
- Being tested
- BIS Monitor
- Keywords
- OHCA, BIS, ROSC, prehospital, PRU
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BIS Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Prehospital phase, on average 60 minutes.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Prehospital phase, on average 30 minutes.
ICU care
To assess all timings of interventions on ICU indicating irreversible HIBI.
Measured: ICU stay, on average 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2024
- Primary completion23 Apr 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072092
- Sponsor's protocol ID
- V2.7.1
- Acronym
- FEICA
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data will be made available on specific requests.
Publications
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.
PubMed 32027980Sandroni 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.
PubMed 36762679Chang 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.
PubMed 32365854Arbas-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.
PubMed 35570124Eichinger 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.
PubMed 40010837
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT06072092
- Acronym / sponsor ID
- FEICA / V2.7.1
- Conditions
- Out-Of-Hospital Cardiac Arrest, BIS
- Keywords
- OHCA, BIS, ROSC, prehospital, PRU
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest adult patients | – | Device: BIS MonitorAll patients aged ≥18 years and in out-of-hospital cardiac arrest (OHCA) on arrival at the physician response unit (PRU) in Graz, Austria + surroundings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Out-of-hospital cardiac arrest adult patients
Key inclusion criteria (2 listed)
- Age ≥18 years
- In out-of-hospital cardiac arrest (OHCA)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS MonitorNo 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. | Device | Out-of-hospital cardiac arrest adult patients |
Primary outcome
Feasibility of BIS prehospital via quality parameters.
Time frame: 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.
Time frame: Prehospital phase, on average 60 minutes.
The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling.
4 secondary outcomes
Prediction of neurological outcome.
Time frame: Prehospital phase, on average 60 minutes.
CPR quality
Time frame: Prehospital phase, on average 30 minutes.
Sedation at ROSC
Time frame: Prehospital phase, on average 30 minutes.
ICU care
Time frame: ICU stay, on average 4 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 32027980Grasner 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.
- Background: PubMed 36762679Sandroni 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.
- Background: PubMed 32365854Chang 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.
- Background: PubMed 35570124Arbas-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.
- Derived from this study: PubMed 40010837Eichinger 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.
- Individual participant dataSharing planned: Undecided. Anonymized data will be made available on specific requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and BIS, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of BIS prehospital via quality parameters. (time frame: From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072092, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.