Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT04258020
Status:
TERMINATED
Last Update Posted:
2022-01-13
First Post:
2020-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Postextubation Management in Patients at Risk for Extubation Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kiran.devulapally@ohiohealth.com', 'phone': '614-566-9143', 'title': 'Dr. Kiran Devulapally', 'organization': 'OhioHealth'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Through hospital discharge, and average of 10.9 days.', 'description': 'All patients were assessed for adverse events through hospital discharge', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Re-intubation Within 72 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours following extubation', 'description': 'The number of patients who require re-intubation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': 'Re-intubation Within 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week following extubation', 'description': 'The number of patients who require re-intubation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': 'Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '1.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'Hospital length of stay', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': 'Ventilator Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'The total duration of time patients spend on a ventilator', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'The proportion of patients who expire during the hospital stay', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': 'Adverse Event Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 1 week following extubation', 'description': 'The proportion of patients experiencing an adverse event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}, {'type': 'SECONDARY', 'title': '30-day Readmission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'OG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days following discharge', 'description': 'The proportion of patients who require re-admission within 30 days of discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the study was terminated (halted prematurely), no historical control data were collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'FG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two participants in the experimental group withdrew from the study prior to intervention. One participant in the experimental group withdrew consent at time of regained capacity. Because the study was terminated (halted prematurely) no data were collected for the historical control group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: Alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation\n\nBiPAP: Bilevel Positive Airway Pressure (BiPAP) oxygen administration\n\nHFNC: Heated High Flow Nasal Cannula oxygen administration'}, {'id': 'BG001', 'title': 'Historical Control: Standard of Care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Because the prospective group was terminated, no data collection for the historical control was collected.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-23', 'size': 475314, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T14:44', 'hasProtocol': True}, {'date': '2020-09-23', 'size': 336318, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-04T11:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Significant impact of COVID pandemic on ability to conduct study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2020-01-27', 'resultsFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-04', 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-intubation Within 72 Hours', 'timeFrame': '72 hours following extubation', 'description': 'The number of patients who require re-intubation'}], 'secondaryOutcomes': [{'measure': 'Re-intubation Within 1 Week', 'timeFrame': '1 week following extubation', 'description': 'The number of patients who require re-intubation'}, {'measure': 'Length of Stay', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'Hospital length of stay'}, {'measure': 'Ventilator Time', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'The total duration of time patients spend on a ventilator'}, {'measure': 'Mortality', 'timeFrame': 'Through hospital discharge, an average of 10.9 ± 1.91 days', 'description': 'The proportion of patients who expire during the hospital stay'}, {'measure': 'Adverse Event Rate', 'timeFrame': 'Through 1 week following extubation', 'description': 'The proportion of patients experiencing an adverse event'}, {'measure': '30-day Readmission', 'timeFrame': '30 days following discharge', 'description': 'The proportion of patients who require re-admission within 30 days of discharge'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventilatory Failure']}, 'descriptionModule': {'briefSummary': 'At the time of weaning from mechanical ventilation, patients with heart and/or lung conditions will be given oxygen support with alternating bilevel positive airway pressure (BiPAP; oxygen via face mask) and heated high flow nasal cannula oxygen (HFNC; oxygen via nasal cannula) to see if this method reduces the likelihood of re-intubation.', 'detailedDescription': 'It is clinically challenging to predict when patients can be successfully removed from mechanical ventilation (MV). Liberating high-risk patients such as the elderly and those with complex, chronic cardiac or pulmonary diseases from MV is particularly challenging.\n\nEvidence from randomized trials and meta-analyses suggests that the type of postextubation supportive care provided, such as oxygen delivery via nose or mouth, may affect the risk of reintubation. However, it is unclear which of many possible postextubation management protocols results in the best patient outcomes, particularly for this subset of high-risk patients.\n\nThe purpose of this study is therefore to assess a standardized combined protocol of postextubation oxygen delivery consisting of early, alternating BiPAP with HFNC over 24 hours following extubation. BiPAP and HFNC are both currently provided to patients as standard of care, based on clinician judgement; however, the timing and nature of the methods are variable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented high-risk factors of interest \\[congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and/or positive fluid balance\\]\n* The modified rapid shallow breathing index on day of extubation must be between 58-105 breaths per minute per liter (breaths/min/L)\n* Patient must successfully complete spontaneous breathing trial and be determined eligible for extubation\n* Only primary extubations will be included\n\nExclusion Criteria:\n\n* Undergoing terminal extubation or placed on comfort care\n* Home ventilator use\n* Any contraindication that would preclude the postextubation protocol (e.g., facial trauma, tracheotomy, or any other reason that would preclude use of BiPAP or HFNC)'}, 'identificationModule': {'nctId': 'NCT04258020', 'briefTitle': 'Postextubation Management in Patients at Risk for Extubation Failure', 'organization': {'class': 'OTHER', 'fullName': 'OhioHealth'}, 'officialTitle': 'Exploratory Trial to Improve Postextubation Management for Patients at Risk for Extubation Failure', 'orgStudyIdInfo': {'id': '1332767'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: alternating BiPAP and HFNC', 'description': 'Patients will be placed on alternating BiPAP and HFNC for 24 hours following extubation', 'interventionNames': ['Device: BiPAP', 'Device: HFNC']}, {'type': 'NO_INTERVENTION', 'label': 'Historical Control: standard of care', 'description': "A historical control cohort will be composed of patients treated according to their physician's standard of care following removal from mechanical ventilation."}], 'interventions': [{'name': 'BiPAP', 'type': 'DEVICE', 'description': 'Bilevel Positive Airway Pressure (BiPAP) oxygen administration', 'armGroupLabels': ['Experimental: alternating BiPAP and HFNC']}, {'name': 'HFNC', 'type': 'DEVICE', 'description': 'Heated High Flow Nasal Cannula oxygen administration', 'armGroupLabels': ['Experimental: alternating BiPAP and HFNC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OhioHealth Grant Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Kiran Devulapally, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OhioHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OhioHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}