Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03432351
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2018-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multi-center Isoelectric EEG Study in Children Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 687}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of isoelectric EEG events in young children.', 'timeFrame': 'Up to 6 months after EEG recording', 'description': 'Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels.'}], 'secondaryOutcomes': [{'measure': 'Discontinuity of isoelectric EEG events among age groups', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Patient age associated with isoelectric EEG events will be analyzed using a Pearson Chi square test to compare discontinuity of isoelectric EEG events among the age groups'}, {'measure': 'Association of isoelectric EEG events between gender groups', 'timeFrame': 'Up to 12 months after EEG recording', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate will be used to analyze patient gender associated with isoelectric EEG events'}, {'measure': 'Patient Weight associated with isoelectric EEG events', 'timeFrame': 'Up to 12 months after EEG recording', 'description': 'Weight (kg)'}, {'measure': "Changes in patient's physical status associated with isoelectric EEG events", 'timeFrame': 'Up to 12 months after EEG recording', 'description': "Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine any association between the patient's physical status outcome associated with isoelectric EEG events."}, {'measure': 'Patient Gestational Age associated with isoelectric EEG events', 'timeFrame': 'Up to 12 months after EEG recording', 'description': 'Gestational Age (weeks)'}, {'measure': 'Procedure length associated with isoelectric EEG events', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Procedure length (min)'}, {'measure': 'Incidence of anesthetic type', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine incidence of anesthetic type (gas vs. TIVA) associated with isoelectric EEG events.'}, {'measure': 'Anesthesia dose', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in anesthesia dose associated with isoelectric EEG events.'}, {'measure': 'Heart rate associated with isoelectric EEG events', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in heart rate (beats per minute) associated with isoelectric EEG events.'}, {'measure': 'Blood pressure associated with isoelectric EEG events', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in blood pressure (mmHg) associated with isoelectric EEG events.'}, {'measure': 'End tidal carbon dioxide (CO2) associated with isoelectric EEG events.', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Sample t-test or Wilcoxon rank-sum test, as appropriate, will be used to determine variation in end tidal CO2 (mmHg) associated with isoelectric EEG events.'}, {'measure': 'Anesthesia Recovery time associated with isoelectric EEG events.', 'timeFrame': 'Up to 12 months after EEG recording.', 'description': 'Recovery time (min)'}, {'measure': 'Changes in quality of life', 'timeFrame': 'Up to 2 months after EEG recording', 'description': "The patient's parent or guardian will complete the PedsQL questionnaire, which measures pediatric quality of life. It consist of up to 45 questions for a total score ranging from 0 to 180. The lower the total score, the better the outcome."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EEG', 'Electroencephalography', 'Pediatric anesthesia'], 'conditions': ['Electroencephalography', 'General Anesthesia', 'Pediatric Anesthesia']}, 'descriptionModule': {'briefSummary': 'Multi-center, prospective, observational study investigating the incidence of isoelectric electroencephalography (EEG) events and the associated peri-operative factors in infants 0-3yo undergoing general anesthesia.', 'detailedDescription': 'Study will consist of placing a forehead EEG on the subject prior to induction of general anesthesia. EEG recording will continue until the end of anesthesia care. The anesthesiologist will be blinded to the EEG results during the study. Peri-operative factors such as demographics, vital signs, medications, etc... will also be recoded. Each site is expected to enroll up to 75 patients to provide at least 50 evaluable subjects. EEG files will be reviewed after recordings.\n\nAfter informed consent has been obtained, the subject will receive standard anesthetic care as administered by the anesthesia provider, who will be blinded to the EEG display and data. EEG recording will continue until the end of anesthesia care.\n\nAfter the recording, the EEG file will be reviewed and the number and duration of isoelectric events will be analyzed. Additional data that will be recorded include: patient demographic and perioperative factors (surgical procedure, anesthetic medications, end tidal anesthetic levels, induction and recovery room behavior, physiologic data, and time-stamps for intraoperative event. Post-operative questionnaire may also be sent to parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '0-36 month old children undergoing general anesthesia for surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0 to 36 (inclusive) months\n* Greater than 36 weeks post-menstrual age (PMA) on the day of study\n* Undergo general anesthesia for surgery that is expected to last more than 30 minutes (combined anesthesia and surgical time).\n* Anesthetic maintenance with Sevoflurane if using volatile anesthetic or Propofol infusion if using total intravenous anesthetic.\n* Expected airway management with a Laryngeal Mask Airway (LMA) or tracheal tube.\n* Parental/legal guardian permission (informed consent) obtained\n\nExclusion Criteria:\n\n* American Society of Anesthesiology (ASA) (physical status) greater than 3\n* Structural/anatomical frontal brain malformations or other circumstances that make it difficult to apply the sensor to the forehead.\n* History of abnormal EEG or severe neurological abnormalities.\n* Scheduled for surgery above the neck, cardiac, brain, or emergency surgery.\n* Known allergy or adverse reaction to ECG adhesives.\n* On a sedative infusion (eg, propofol, morphine, fentanyl, midazolam, dexmedetomidine, ketamine) or recently on a sedative infusion (discontinued \\<24 hours ago)\n* Received ketamine within 8 hours prior to the induction of general anesthesia'}, 'identificationModule': {'nctId': 'NCT03432351', 'briefTitle': 'Multi-center Isoelectric EEG Study in Children Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'An International Multicenter Study of Isoelectric EEG Events in Infants and Young Children During Anesthesia for Surgery', 'orgStudyIdInfo': {'id': '17-014608'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children: 0-36mo', 'description': "EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention."}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital (RCH, Melbourne, Australia)", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6008', 'city': 'Subiaco', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children (PMH, Perth, Australia)', 'geoPoint': {'lat': -31.9485, 'lon': 115.8268}}, {'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing Children's Hospital/Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510620', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '110003', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Shanghai Jiao Tong university school of medicine / Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University, China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610071', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University", 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '3015', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': "Erasmus MC Sophia Children's Hospital", 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Geneva', 'country': 'Switzerland', 'facility': 'University of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Paula Hu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Manager'}, {'name': 'Justin Skowno', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sydney Children's Hospitals Network"}, {'name': 'Andrew J Davidson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Royal Children's Hospital"}, {'name': 'Britta Regli-von Ungern-Sternberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital for Children, Perth, Australia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Limited dataset will be available to other researchers for up to 2 years after end of study.', 'ipdSharing': 'YES', 'description': 'Coded limited dataset with minimum necessary protected health information (PHI) such as dates will be shared with Masimo and statisticians for EEG interpretation and data analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': "Sydney Children's Hospitals Network", 'class': 'OTHER'}, {'name': "Royal Children's Hospital", 'class': 'OTHER'}, {'name': 'Princess Margaret Hospital for Children', 'class': 'OTHER'}, {'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "Yuying Children's Hospital of Wenzhou Medical University", 'class': 'OTHER'}, {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, {'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'University of Geneva, Switzerland', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}