Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-27 @ 5:49 PM
Study NCT ID:
NCT06072092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2023-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frontal EEG in OHCA Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of BIS prehospital via quality parameters.', 'timeFrame': 'From PRU arrival until hand-over to the hospital (prehospital phase), on average 60 minutes.', 'description': '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.'}, {'measure': 'Feasibility of BIS prehospital via a questionnaire.', 'timeFrame': 'Prehospital phase, on average 60 minutes.', 'description': 'The prehospital BIS feasibility will be assessed with a short questionnaire about the application and its handling.'}], 'secondaryOutcomes': [{'measure': 'Prediction of neurological outcome.', 'timeFrame': 'Prehospital phase, on average 60 minutes.', 'description': '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.'}, {'measure': 'CPR quality', 'timeFrame': 'Prehospital phase, on average 30 minutes.', 'description': 'To assess the correlation of BIS and etCO2 values in OHCA patients receiving CPR under evaluation of CPR quality.'}, {'measure': 'Sedation at ROSC', 'timeFrame': 'Prehospital phase, on average 30 minutes.', 'description': 'Patients with higher mean BIS values (\\>25) will require earlier and more sedation than patients with values below.'}, {'measure': 'ICU care', 'timeFrame': 'ICU stay, on average 4 days.', 'description': 'To assess all timings of interventions on ICU indicating irreversible HIBI.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OHCA', 'BIS', 'ROSC', 'prehospital', 'PRU'], 'conditions': ['Out-Of-Hospital Cardiac Arrest', 'BIS']}, 'referencesModule': {'references': [{'pmid': '32027980', 'type': 'BACKGROUND', '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.'}, {'pmid': '36762679', 'type': 'BACKGROUND', '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.'}, {'pmid': '32365854', 'type': 'BACKGROUND', '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.'}, {'pmid': '35570124', 'type': 'BACKGROUND', '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.'}, {'pmid': '40010837', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'The research project is designed to contribute to the low survival discharge rates of OHCA patients in Europe, which is currently around 8%.\n\nObjectives:\n\n1. To assess the feasibility of BIS monitoring in the prehospital environment during CPR and ROSC.\n2. To determine the optimal mean BIS cut-off value after ROSC (Return of Spontaneous Circulation) during the prehospital phase.\n3. To assess BIS and etCO2 values in OHCA patients under evaluation of CPR quality.\n4. To understand the sedation needs based on BIS values.\n5. To identify the timing of interventions in the ICU that signify irreversible HIBI.\n\nPhases:\n\n* Phase 1: The initial focus is assessing BIS and etCO2 values in OHCA patients receiving CPR.\n* Phase 2: We will investigate whether patients with higher mean BIS values (\\>25) require earlier and more sedation than those with lower BIS values.\n* Phase 3: This phase will examine ICU interventions and their timing to ascertain which patients are at risk of suffering from irreversible HIBI.\n\nMethodology:\n\nThe 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.\n\nTimeline:\n\nThe study will span approximately 14 months, starting with patient recruitment, data collection, and analysis and ending with the publication of results.\n\nThis project aims to provide critical insights into the feasibility and effectiveness of BIS monitoring in improving neurological outcomes for OHCA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Out-of-hospital cardiac arrest adult patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* In out-of-hospital cardiac arrest (OHCA)\n\nExclusion Criteria:\n\n* BIS application non-possible (for example, due to massive facial trauma)\n* No ALS (Advanced Life Support) performed\n* Clear signs of death\n* Sustained ROSC (\\>5 minutes after CPR with signs of life) on the arrival of the emergency physician'}, 'identificationModule': {'nctId': 'NCT06072092', 'acronym': 'FEICA', 'briefTitle': 'Frontal EEG in OHCA Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Frontal EEG in Out-of-hospital Cardiac Arrest - a Prospective Observational Feasibility Study', 'orgStudyIdInfo': {'id': 'V2.7.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Out-of-hospital cardiac arrest adult patients', 'description': '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.', 'interventionNames': ['Device: BIS Monitor']}], 'interventions': [{'name': 'BIS Monitor', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Out-of-hospital cardiac arrest adult patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized data will be made available on specific requests.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}