Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-05 @ 6:46 PM
Study NCT ID:
NCT02184169
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2014-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)
Sponsor:
Organization:
Raw JSON
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'HLHS', 'description': 'Patients undergoing palliative repair.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TGA/IVS', 'description': 'Surgical repair of TGA.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygen Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HLHS', 'description': 'Patients undergoing palliative repair.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}, {'id': 'OG001', 'title': 'TGA With/Without VSD', 'description': 'Surgical repair of TGA.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'spread': '12', 'groupId': 'OG000'}, {'value': '102', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While mechanically 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Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'While mechanically ventilated, up to 14 days', 'description': 'A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.', 'unitOfMeasure': 'L/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The average cardiac index was measured for each patient twice per day'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HLHS', 'description': 'Patients undergoing palliative repair.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}, {'id': 'FG001', 'title': 'TGA With/Without VSD', 'description': 'Surgical repair of TGA.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HLHS', 'description': 'Patients undergoing palliative repair.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}, {'id': 'BG001', 'title': 'TGA/IVS', 'description': 'Surgical repair of TGA.\n\nGeneral Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments: Breath to breath VO2 measurements\n\nEdwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr: Edwards continuous SVO2 measurement system'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '.1', 'spread': '.1', 'groupId': 'BG000'}, {'value': '.1', 'spread': '.1', 'groupId': 'BG001'}, {'value': '.1', 'spread': '.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Region of surgery', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-02-01', 'size': 2134043, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-08T20:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-01', 'studyFirstSubmitDate': '2014-07-02', 'resultsFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-01', 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Consumption', 'timeFrame': 'While mechanically ventilated, up to 14 days', 'description': 'Oxygen consumption is the mass of oxygen gas consumed per minute, measured as the difference between oxygen mass inspired versus exhaled per minute.'}], 'secondaryOutcomes': [{'measure': 'Computed Cardiac Index', 'timeFrame': 'While mechanically ventilated, up to 14 days', 'description': 'A calculated estimate of cardiac index/systemic blood flow based on the Fick principle.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemodynamics', 'neonatal', 'cardiac disease', 'congenital heart disease', 'volumetric oxygen consumption'], 'conditions': ['Transposition of the Great Vessels', 'Hypoplastic Left Heart Syndrome', 'Oxygen Consumption Based Assessment of Hemodynamics']}, 'referencesModule': {'references': [{'pmid': '27806964', 'type': 'RESULT', 'citation': 'Mills KI, Kaza AK, Walsh BK, Bond HC, Ford M, Wypij D, Thiagarajan RR, Almodovar MC, Quinonez LG, Baird CW, Emani SE, Pigula FA, DiNardo JA, Kheir JN. Phosphodiesterase Inhibitor-Based Vasodilation Improves Oxygen Delivery and Clinical Outcomes Following Stage 1 Palliation. J Am Heart Assoc. 2016 Nov 2;5(11):e003554. doi: 10.1161/JAHA.116.003554.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the Oxy-CAHN study is to improve the monitoring capabilities of newborn infants recovering from congenital heart surgery. Currently, we utilize important but unsophisticated measures, such as vital signs and lactate measurements, to monitor these patients. Although they are useful in categorizing patients as well or unwell, these signs currently lack the power quantify a patient's risk for cardiac arrest. More to the point, they are mostly indirect measures of what we really are assessing, which is tissue oxygen delivery.\n\nOur group has significant expertise with devices which quantify the amount of oxygen that a baby consumes every minute. Historically, these values are more commonly used in combination with other measures to assess nutritional and metabolism status. In critically ill patients, however, the volume of oxygen consumed by a patient may be limited by the amount of oxygen their circulation delivers. This may represent a critical relationship, which has been previously described, but not exploited for the purpose of identifying patients with critically low oxygen delivery.\n\nThe aims of this study are therefore (1) to demonstrate that oxygen consumption can be safely and precisely measured continuously in newborns undergoing one of two common congenital heart surgeries, (2) to determine whether postoperative circulatory failure is associated with a precedent change in oxygen consumption, and (3) to determine whether the addition of the oxygen-based measurements (including oxygen consumption and venous oxygen saturations) to standardly measured parameters will add power in predicting which patients will experience postoperative circulatory failure.\n\nIf successful, this study may improve our capacity to non-invasively and continuously monitor patients following the highest risk congenital heart surgeries, and in the future,to create an algorithm which quantifies a patients risk for having a cardiac arrest. This may permit providers to intervene on these patients earlier, improving the morbidity and mortality associated with congenital heart disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients from birth to 6 months of age\n2. HLHS AND no prior operations AND planned S1P or HPOR d-TGA/IVS AND planned ASO\n3. Written parental informed consent\n\nExclusion Criteria:\n\n1. Weight \\< 2 kg\n2. Disease specific A. HLHS patients: Infants whose surgical plan includes a neonatal biventricularrepair will be excluded.\n\n B. d-TGA/IVS patients: Newborns with any additional cardiac defect other than an atrial septal defect will be excluded.\n3. Patients on ECMO preoperatively\n4. Clinically significant tracheo-esophageal fistula or known preoperative air leak'}, 'identificationModule': {'nctId': 'NCT02184169', 'acronym': 'Oxy-CAHN', 'briefTitle': 'Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Oxygen Consumption-based Assessments of Hemodynamics in Neonates Following Congenital Heart Surgery (Oxy-CAHN Study)', 'orgStudyIdInfo': {'id': 'IRB-P00006630'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLHS', 'description': 'Patients undergoing palliative repair.', 'interventionNames': ['Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments', 'Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TGA', 'description': 'Surgical repair of TGA.', 'interventionNames': ['Device: General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments', 'Device: Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr']}], 'interventions': [{'name': 'General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments', 'type': 'DEVICE', 'description': 'Breath to breath VO2 measurements', 'armGroupLabels': ['HLHS', 'TGA']}, {'name': 'Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr', 'type': 'DEVICE', 'description': 'Edwards continuous SVO2 measurement system', 'armGroupLabels': ['HLHS', 'TGA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'John Kheir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'General Electric', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'John Kheir', 'investigatorAffiliation': "Boston Children's Hospital"}}}}