Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-01-01 @ 1:39 AM
Study NCT ID:
NCT05418634
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2022-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point-of-care EEG in the Pediatric Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013226', 'term': 'Status Epilepticus'}], 'ancestors': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG', 'timeFrame': 'Baseline', 'description': 'All patients with impaired consciousness presenting to the PED will receive a pocEEG. We analyse the number of patients with SE, NCSE, and encephalitis diagnosed by pocEEG'}, {'measure': 'Agreement pocEEG vs. conventional EEG in epilepsy clinic', 'timeFrame': 'Baseline', 'description': 'Agreement of pocEEG and cEEG findings in simultaneous tracings carried out during routine care in the epilepsy clinic.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric emergency medicine', 'pediatric neurology', 'status epliepticus', 'non-convulsive status epilepticus', 'altered mental status'], 'conditions': ['Status Epilepticus', 'Non-Convulsive Status Epilepticus', 'Altered Mental Status']}, 'referencesModule': {'references': [{'pmid': '37763178', 'type': 'BACKGROUND', 'citation': 'Simma L, Romano F, Schmidt S, Ramantani G, Bolsterli BK. Integrating Neuromonitoring in Pediatric Emergency Medicine: Exploring Two Options for Point-of-Care Electroencephalogram (pocEEG) via Patient Monitors-A Technical Note. J Pers Med. 2023 Sep 20;13(9):1411. doi: 10.3390/jpm13091411.'}, {'pmid': '33127740', 'type': 'BACKGROUND', 'citation': 'Simma L, Bauder F, Schmitt-Mechelke T. Feasibility and usefulness of rapid 2-channel-EEG-monitoring (point-of-care EEG) for acute CNS disorders in the paediatric emergency department: an observational study. Emerg Med J. 2021 Dec;38(12):919-922. doi: 10.1136/emermed-2020-209891. Epub 2020 Oct 30.'}, {'pmid': '28072672', 'type': 'BACKGROUND', 'citation': 'Nozawa M, Terashima H, Tsuji S, Kubota M. A Simplified Electroencephalogram Monitoring System in the Emergency Room. Pediatr Emerg Care. 2019 Jul;35(7):487-492. doi: 10.1097/PEC.0000000000001033.'}, {'pmid': '30528574', 'type': 'BACKGROUND', 'citation': 'Yamaguchi H, Nagase H, Nishiyama M, Tokumoto S, Ishida Y, Tomioka K, Tanaka T, Fujita K, Toyoshima D, Nishimura N, Kurosawa H, Nozu K, Maruyama A, Tanaka R, Iijima K. Nonconvulsive Seizure Detection by Reduced-Lead Electroencephalography in Children with Altered Mental Status in the Emergency Department. J Pediatr. 2019 Apr;207:213-219.e3. doi: 10.1016/j.jpeds.2018.11.019. Epub 2018 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The researchers investigate the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an ongoing epileptic seizure ("status epilepticus"). In addition, the researchers will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.', 'detailedDescription': 'Non-traumatic, acute central nervous system (CNS) disorders are amongst the most frequent emergencies in childhood. In Switzerland, CNS disorders are the top ranking presentation of critically ill children. Many pediatric neurological emergencies such as coma, acute encephalopathies with impaired consciousness or agitation, or acute focal deficits, are associated with changes of cortical electrical activity detectable by the electroencephalogram (EEG). Of particular concern are status epilepticus (SE) and non-convulsive status epilepticus (NCSE). Previous studies have shown that an EEG can yield important diagnostic information and aid in decision-making. However, conventional EEG-recordings are resource intensive (time, staff), and hardly available outside of regular working hours. Point-of-care EEG (pocEEG) has proven helpful for evaluating impaired consciousness, detecting NCSE, and monitoring therapy in ongoing SE. In a retrospective cohort study from Japan patients with impaired consciousness were diagnosed with non-convulsive seizures in pocEEG, supporting the view that pocEEG can be applied by ED physicians, even in the absence of a neurologist, and can aid the detection and treatment of non-convulsive seizures. Another study, also from Japan, reported that abnormalities were detected in 20% of patients by using pocEEG in an ED setting. The aims of this study are:\n\n* To prospectively assess the feasibility and utility of pocEEG for NCSE detection in children presenting with impaired consciousness in the PED\n* To evaluate the interpretation accuracy of pocEEG by pediatric emergency medicine (PEM) providers after a teaching module.\n* To compare pocEEG to the "gold standard" of simultaneously recorded conventional EEG in patients undergoing routine cEEG in the epilepsy outpatient clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All pediatric patients presenting to the PED or the epilepsy clinic fulfilling the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGeneral:\n\nPED:\n\n* Pediatric patients with unexplained impaired consciousness, suspicion of NCSE, active SE presenting to the PED\n* Informed consent of patient of parents/persons responsible, if possible, otherwise emergency situation procedure (according to national regulations for research in emergency situations)\n\nCLINIC:\n\n* Informed consent as documented by signature\n* Pediatric patients undergoing cEEG in the outpatient epilepsy clinics\n* Either suspected/ to rule out epilepsy or established diagnosis of epilepsy\n\nExclusion Criteria:\n\nPED:\n\n* AMS of known etiology or another diagnosis\n* Declined informed consent\n\nCLINIC:\n\n* Failure to provide signed informed consent\n* Changes in health condition which might interfere with the EEG recording.'}, 'identificationModule': {'nctId': 'NCT05418634', 'briefTitle': 'Point-of-care EEG in the Pediatric Emergency Department', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'The Role of Point-of-care EEG in the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '2022-00842'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric Emergency Department (PED)', 'description': 'PED: Patients presenting with unexplained impaired consciousness or active SE:\n\nTo investigate the role of pocEEG in the PED, we will collect all pocEEG tracings of all children with unexplained impaired consciousness or active SE, for whom written consent has been obtained. We will document the interpretation of the respective pocEEGs by the PEM physician and compare it to the interpretation of the neuropediatrician on call. The research team will also perform a post-hoc analysis.', 'interventionNames': ['Other: point of care EEG']}, {'label': 'Epilepsy Clinic', 'description': 'CLINIC: Patients with either suspected epilepsy or established diagnosis of epilepsy will be recruited for simultaneous recording of cEEG and pocEEG in the epilepsy outpatient clinic will help define and investigate the limitations of pocEEG.', 'interventionNames': ['Other: point of care EEG']}], 'interventions': [{'name': 'point of care EEG', 'type': 'OTHER', 'description': 'For pocEEG, scalp electrodes are applied in five locations.', 'armGroupLabels': ['Epilepsy Clinic', 'Pediatric Emergency Department (PED)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Georgia Ramantani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University Children's Hospital, Zurich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'collaborators': [{'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PEM Attending', 'investigatorFullName': 'Leopold Simma', 'investigatorAffiliation': "University Children's Hospital, Zurich"}}}}