Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT03865316
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2019-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalResearchDept@masimo.com', 'phone': '949-297-7000', 'title': 'Cristina Johnson', 'organization': 'Masimo Corporation'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 8 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'SedLine Vs Comparator Test Group', 'description': "SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.", 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 1, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Petechial Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation of Sedation Indices Performance Across Anesthesia Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SedLine Vs Comparator Test Group', 'description': "SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system."}], 'classes': [{'categories': [{'measurements': [{'value': '0.8314', 'groupId': 'OG000', 'lowerLimit': '0.8240', 'upperLimit': '0.8385'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of surgery', 'description': "The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.", 'unitOfMeasure': 'Pearson r', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the complexity of data collection, complete data for analysis was available from 61 subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SedLine Vs Comparator Test Group', 'description': "SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Procedure Cancelled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Equipment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SedLine Vs Comparator Test Group', 'description': "SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}, {'title': 'American Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-02', 'size': 1128643, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-03-11T13:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-11', 'studyFirstSubmitDate': '2019-02-04', 'resultsFirstSubmitDate': '2022-03-11', 'studyFirstSubmitQcDate': '2019-03-05', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-11', 'studyFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Sedation Indices Performance Across Anesthesia Range', 'timeFrame': 'Duration of surgery', 'description': "The correlation was computed using 1 min average values between the PSi and the comparator's sedation index."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '33823811', 'type': 'DERIVED', 'citation': 'Jones JH, Nittur VR, Fleming N, Applegate RL 2nd. Simultaneous comparison of depth of sedation performance between SedLine and BIS during general anesthesia using custom passive interface hardware: study protocol for a prospective, non-blinded, non-randomized trial. BMC Anesthesiol. 2021 Apr 6;21(1):105. doi: 10.1186/s12871-021-01326-5.'}]}, 'descriptionModule': {'briefSummary': "The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years old and older at the time of consent.\n* ASA status I, II, or III.\n* English-speaking subjects.\n* Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).\n\nExclusion Criteria:\n\n* Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.\n* Subjects who are developmentally delayed.\n* Subjects deemed not suitable for study at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT03865316', 'briefTitle': 'Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia', 'orgStudyIdInfo': {'id': 'APPL0009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SedLine Vs Comparator Test Group', 'interventionNames': ['Device: SedLine Vs Comparator Test Group']}], 'interventions': [{'name': 'SedLine Vs Comparator Test Group', 'type': 'DEVICE', 'description': "Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.", 'armGroupLabels': ['SedLine Vs Comparator Test Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}