Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 6:56 AM
Study NCT ID:
NCT03383757
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2017-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
U-TruSignal SpO2 Testing in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephanie.karwedsky@ge.com', 'phone': '262-443-7008', 'title': 'Clinical Affairs Project Manager', 'organization': 'GE Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 hour.', 'eventGroups': [{'id': 'EG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.", 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 0, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy Root Mean Square (ARMS) Per Data Pair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."}], 'classes': [{'title': 'TS-AF ARMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'TS-SE ARMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes per data pair', 'description': 'Compare observations of Peripheral Capillary Oxygen Saturation (SpO2- measured by the test pulse oximeter system) and Oxygen Saturation of Arterial Blood (SaO2) values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood).', 'unitOfMeasure': 'percentage of oxygen saturated hemoglobi', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants may have multiple data points with multiple sensors.'}, {'type': 'SECONDARY', 'title': 'Continuous SpO2 Measurements During Data Collection Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."}], 'classes': [{'title': 'TS-AF <=1% of invalid data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'TS-AF >1% of invalid data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TS-SE <=1% of invalid data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'TS-SE >1% of invalid data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes per data pair', 'description': 'The secondary objective of the study was to demonstrate U-TruSignal collects substantially continuous SpO2 measurements during a data collection interval. All time the sensors were worn and data collected across participants were reviewed for invalid data within each data pair. For the data pairs that had moments of invalid data, a calculation was conducted (invalid data/complete data for data pair) to establish percentage of invalid data per sensor. For each sensor type the percentage of invalid data (%) was calculated. Sensor readings were grouped together across participants and are being reported as the total number of invalid readings over the total number of readings for all participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '78 Participants analyzed, 38 with TS-AF sensor, 40 with TS-SE sensor. Participants may have multiple data points with multiple sensors.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Type and Number of AEs, SAEs, and Device Issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."}], 'classes': [{'title': 'TruSignal AllFit Sensor AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TruSignal AllFit Sensor SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TruSignal AllFit Sensor Device Issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TruSignal Sensitive Sensor AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TruSignal Sensitive Sensor SAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TruSignal Sensitive Sensor Device Issues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes per data pair', 'description': 'Collect safety information, including type and number of AE s, SAEs, and device issues.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'AE, SAE and Device Issues were measured for each sensor.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured. Subject may have one or both sensors applied.\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}]}, {'type': 'TruSignal AllFit Sensor Subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'TruSignal Sensitive Sensor Subjects', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}]}, {'type': 'TruSignal AllFit Sensor Data Pairs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}, {'type': 'TruSignal Sensitive Sensor Data Pairs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SpO2 Sensor Application & Blood Draw', 'description': "All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured\n\nSpO2 Sensor application \\& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '4.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-01', 'size': 5578544, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-15T16:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2017-11-03', 'resultsFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2017-12-19', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-03', 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Type and Number of AEs, SAEs, and Device Issues', 'timeFrame': '30 minutes per data pair', 'description': 'Collect safety information, including type and number of AE s, SAEs, and device issues.'}], 'primaryOutcomes': [{'measure': 'Accuracy Root Mean Square (ARMS) Per Data Pair', 'timeFrame': '30 minutes per data pair', 'description': 'Compare observations of Peripheral Capillary Oxygen Saturation (SpO2- measured by the test pulse oximeter system) and Oxygen Saturation of Arterial Blood (SaO2) values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood).'}], 'secondaryOutcomes': [{'measure': 'Continuous SpO2 Measurements During Data Collection Interval', 'timeFrame': '30 minutes per data pair', 'description': 'The secondary objective of the study was to demonstrate U-TruSignal collects substantially continuous SpO2 measurements during a data collection interval. All time the sensors were worn and data collected across participants were reviewed for invalid data within each data pair. For the data pairs that had moments of invalid data, a calculation was conducted (invalid data/complete data for data pair) to establish percentage of invalid data per sensor. For each sensor type the percentage of invalid data (%) was calculated. Sensor readings were grouped together across participants and are being reported as the total number of invalid readings over the total number of readings for all participants'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulse Oximetry']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions \\[50(k)s\\]: Guidance for Industry and Food and Drug Administration Staff.)', 'detailedDescription': "The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device.\n\nThe study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor.\n\nAfter providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject.\n\nThe duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '29 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND\n2. Subjects are \\< 29 days old, and requiring arterial blood samples per the site's standard of care.\n\nExclusion Criteria:\n\n1. Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;\n2. Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;\n3. Neonates with mean arterial blood pressure \\< 20mmHg;\n4. Neonates with congenital diaphragmatic hernia; OR\n5. Neonates under High frequency ventilation therapy."}, 'identificationModule': {'nctId': 'NCT03383757', 'briefTitle': 'U-TruSignal SpO2 Testing in Neonates', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'U-TruSignal SpO2 Testing in Neonates', 'orgStudyIdInfo': {'id': '123.04-2017-GES-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SpO2 Sensor Application & Blood draw', 'description': 'All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured', 'interventionNames': ['Device: SpO2 Sensor application & blood draw']}], 'interventions': [{'name': 'SpO2 Sensor application & blood draw', 'type': 'DEVICE', 'description': "At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.", 'armGroupLabels': ['SpO2 Sensor Application & Blood draw']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33520', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital (TAYS)', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '560099', 'city': 'Bangalore', 'country': 'India', 'facility': 'NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Rajiv Agarwal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center'}, {'name': 'Outi Tammela, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital (TAYS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}