Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-01 @ 3:43 PM
Study NCT ID:
NCT02240368
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2014-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alberto.sciusco@gmail.com', 'title': 'Alberto Sciusco', 'organization': 'University of Foggia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Whole period of study from January 2014 to November 2014', 'description': 'No adverse events were expected. No adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BISPECTRAL Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.61'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '0.67'}, {'value': '0.73', 'groupId': 'OG002', 'lowerLimit': '0.71', 'upperLimit': '0.74'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'bootstrap', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours', 'description': 'The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.\n\nPrediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Entropy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '0.65'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '0.68'}, {'value': '0.72', 'groupId': 'OG002', 'lowerLimit': '0.71', 'upperLimit': '0.74'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'bootstrap', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours', 'description': 'The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.\n\nPrediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BISPECTRAL Index Awaking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '78'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '92'}, {'value': '81', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '88'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia', 'description': 'In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Entropy Awaking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'OG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '71'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '93', 'upperLimit': '98'}, {'value': '86', 'groupId': 'OG002', 'lowerLimit': '78', 'upperLimit': '96'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia', 'description': 'In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'FG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Surgery lasted less then 20 minutes', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Entropy failed to detect more than 50%', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'id': 'BG002', 'title': 'Group 3', 'description': 'Children age between 37 months to 144 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.63', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '24.95', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '82.22', 'spread': '33.8', 'groupId': 'BG002'}, {'value': '43.38', 'spread': '37.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2014-08-31', 'resultsFirstSubmitDate': '2015-05-24', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-12', 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BISPECTRAL Index', 'timeFrame': 'BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours', 'description': 'The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.\n\nPrediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.'}, {'measure': 'Entropy', 'timeFrame': 'Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours', 'description': 'The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.\n\nPrediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions.'}], 'secondaryOutcomes': [{'measure': 'BISPECTRAL Index Awaking', 'timeFrame': 'reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia', 'description': 'In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer'}, {'measure': 'Entropy Awaking', 'timeFrame': 'reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia', 'description': 'In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depth anesthesia monitors', 'Children anesthesia', 'Bispectral monitor', 'Entropy monitor'], 'conditions': ['Anesthesia', 'Child']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.anestesia.unifg.it/', 'label': 'Speciality school of anesthesia of University of Foggia'}, {'url': 'http://www.unifg.it/', 'label': 'University of Foggia'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery setting.\n\nBispectral index (BIS) and Entropy EEG monitors performance and utility is well established in adult general anesthesia.\n\nTheir utility is yet undefined in the pediatric population as age seems to affect their ability to track the cerebral hypnotic state in children.', 'detailedDescription': 'All patients monitored applying standard device for blood pressure, electrocardiogram and pulse oximeter for routine monitor of anesthesia in pediatric surgery. Bispectral VISTA monitor and Entropy monitor applied for monitoring the depth of anesthesia. The investigators will not assign any specific interventions to the subjects of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with age ≤ 12 years old scheduled to undergo general anesthesia and mechanical ventilation for elective surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physical status classification (ASA) I - II\n* general balanced anesthesia\n* mechanically ventilated with laryngeal mask\n\nExclusion Criteria:\n\n* severe developmental delay\n* neurological disorders or receiving treatment with antiepileptic or stimulant\n* patients with preexisting lung or cardiac disease\n* airway abnormalities\n* marked skin sensitivity and conditions where the placement of the BIS and Entropy sensor or process of assessment would interfere with the surgery procedure.\n* patients receiving local anaesthesia, regional block combined with general anaesthesia\n* sedation administered by non anesthesiologists for invasive and noninvasive diagnostic or therapeutic procedures'}, 'identificationModule': {'nctId': 'NCT02240368', 'briefTitle': 'Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery. Bispectral VISTA and ENTROPY Monitor for Pediatric Anesthesia.', 'orgStudyIdInfo': {'id': 'A01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Children age between 1 month to 12 months'}, {'label': 'Group 2', 'description': 'Children age between 13 months and 36 months'}, {'label': 'Group 3', 'description': 'Children age between 37 months to 144 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70100', 'city': 'Foggia', 'state': 'FG', 'country': 'Italy', 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}], 'overallOfficials': [{'name': 'Michele Dambrosio, Medic', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Foggia'}, {'name': 'Gilda Cinnella, Medic', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Foggia'}, {'name': 'Alberto Sciusco, medic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Foggia'}, {'name': 'Pasquale Raimondo, Medic', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Foggia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'collaborators': [{'name': 'University College, London', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Alberto Sciusco', 'investigatorAffiliation': 'University of Foggia'}}}}