Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-29 @ 1:01 AM
Study NCT ID:
NCT03223168
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-04', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamics as characterized by change in pulmonary artery pressure', 'timeFrame': 'Baseline, 45 Minutes', 'description': 'Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.'}, {'measure': 'Hemodynamics as characterized by change in pulmonary blood flow', 'timeFrame': 'Baseline, 45 Minutes', 'description': 'Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.'}, {'measure': 'Hemodynamics as characterized by change in systemic arterial saturation', 'timeFrame': 'Baseline, 45 Minutes', 'description': 'Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.'}, {'measure': 'Hemodynamics as characterized by change in cardiac output', 'timeFrame': 'Baseline, 45 Minutes', 'description': 'Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Failing Fontan Physiology', 'Pediatric Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).\n\nExclusion Criteria:\n\n1. Patients which will likely require intubation for catheterization\n2. Severely depressed systemic ventricular systolic function\n3. Baseline airway obstruction\n4. Plastic bronchitis\n5. Significant OUTFLOW obstruction'}, 'identificationModule': {'nctId': 'NCT03223168', 'briefTitle': 'Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology', 'orgStudyIdInfo': {'id': 'HUM00131186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hayek RTX ventilator', 'description': 'Participants will receive noninvasive negative pressure ventilation.', 'interventionNames': ['Device: Hayek RTX ventilator']}], 'interventions': [{'name': 'Hayek RTX ventilator', 'type': 'DEVICE', 'description': 'Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.', 'armGroupLabels': ['Hayek RTX ventilator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of MIchigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'David Peng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics and Communicable Diseases', 'investigatorFullName': 'David Peng', 'investigatorAffiliation': 'University of Michigan'}}}}