Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT04093661
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of anesthesia', 'timeFrame': '06/2017 - 06/2019', 'description': 'Duration of anesthesia is captured from the patient records and measured until the end of surgery. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study.'}, {'measure': 'Type of surgery', 'timeFrame': '06/2017 - 06/2019', 'description': 'Type of surgery is captured from the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study.'}], 'primaryOutcomes': [{'measure': 'Electroencephalography monitoring changes', 'timeFrame': '06/2017 - 06/2019', 'description': 'The primary objective of this study performed according to an observational post-ad-hoc design measures the perioperative EEG overall power signature. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charité will be enrolled in the study. They are followed up until their discharge from the recovery room.'}], 'secondaryOutcomes': [{'measure': 'Anesthetic depth', 'timeFrame': '06/2017 - 06/2019', 'description': 'Anesthetic stage is related to typical time points during an anesthetic procedure - as "loss of consciousness", "intubation", "stable anesthesia", "extubation", "regain of consciousness". Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.'}, {'measure': 'Medication', 'timeFrame': '06/2017 - 06/2019', 'description': 'Medication data are captured from the patient sheets. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.'}, {'measure': 'Emergence Delirium', 'timeFrame': '06/2017 - 06/2019', 'description': 'Delirium is captured form the PAED Score data in the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.'}, {'measure': 'Pain', 'timeFrame': '06/2017 - 06/2019', 'description': 'Pain scores are captured form the patient records. Approximately 150 children admitted from 06/2017 to 06/2019 to the Charite will be enrolled in the study. They are followed up until their discharge from the recovery room.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depth of Anesthesia']}, 'descriptionModule': {'briefSummary': 'As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\\<=1 year).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children \\<= 1 year undergoing surgery procedure with Electroencephalography Monitoring.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Children \\<= 1 year undergoing surgery procedure\n\nExclusion Criteria:\n\n* Incomplete patient record documentation\n* Pre-existing neurological/psychological conditions'}, 'identificationModule': {'nctId': 'NCT04093661', 'briefTitle': 'Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Retrospective Analysis of Intraoperative Electroencephalography Characteristics in Children Under One Year of Age', 'orgStudyIdInfo': {'id': 'Retro-Baby'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children below 1 year', 'description': 'Children \\<= 1 year for elective surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia Spies, MD, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)', 'investigatorFullName': 'Claudia Spies', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}