Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT04165161
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'For each patient the 4 tests will be performed in a randomized order to limit bias'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of transatrial passage of contrast media', 'timeFrame': '1 day after lung transplantation', 'description': 'Incidence of transatrial passage of contrast media'}], 'secondaryOutcomes': [{'measure': 'Size of PFO, existence of an atrial septal aneurysm', 'timeFrame': '1 day after lung transplantation'}, {'measure': 'Number of postoperative days with mechanical ventilation', 'timeFrame': '30 days after lung transplantation'}, {'measure': 'Incidence of pulmonary graft dysfunction, incidence of stroke, incidence of myocardial ischemia', 'timeFrame': '30 days after lung transplantation'}, {'measure': 'Mortality during the stay in the intensive care unit', 'timeFrame': '30 days after lung transplantation'}, {'measure': 'Mortality during the stay in the hospital', 'timeFrame': '30 days after lung transplantation'}, {'measure': 'Mortality at the postoperative 30-day', 'timeFrame': '30 days after lung transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of FOP found by transesophageal echocardiography in a population of patients undergoing lung transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years old minimum\n* Benefiting from a lung transplant\n* Having an upper vena cava catheter and a lower vena cava catheter set up as part of the usual care\n* Having signed a consent form\n* Affiliated to a insurance scheme or beneficiary (excluding AME)\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Having a contraindication to the insertion of the esophageal ultrasound probe\n* deprived of liberty or under guardianship'}, 'identificationModule': {'nctId': 'NCT04165161', 'acronym': 'FOP-TP', 'briefTitle': 'Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Performance Diagnosis of a Patent Foramen Ovale During Lung Transplantation Using Transesophageal Echocardiography: Comparison of the Injection of Contrast in the Upper and Lower Caval Territories (FOP-TP)', 'orgStudyIdInfo': {'id': '2018_0098'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'superior without positive tele-expiratory pressure', 'description': 'Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation without positive tele-expiratory pressure', 'interventionNames': ['Diagnostic Test: search for a patent foramen ovale']}, {'type': 'OTHER', 'label': 'superior with 10 cmH2O positive tele-expiratory pressure', 'description': 'Diagnostic Test: Contrast injection in the superior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure', 'interventionNames': ['Diagnostic Test: search for a patent foramen ovale']}, {'type': 'OTHER', 'label': 'inferior without positive tele-expiratory pressure', 'description': 'Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation without positive tele-expiratory pressure', 'interventionNames': ['Diagnostic Test: search for a patent foramen ovale']}, {'type': 'OTHER', 'label': 'inferior with 10 cmH2O positive tele-expiratory pressur', 'description': 'Diagnostic Test: Contrast injection in the inferior vena cava territory + controlled ventilation with 10 cmH2O positive tele-expiratory pressure', 'interventionNames': ['Diagnostic Test: search for a patent foramen ovale']}], 'interventions': [{'name': 'search for a patent foramen ovale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;', 'armGroupLabels': ['inferior with 10 cmH2O positive tele-expiratory pressur', 'inferior without positive tele-expiratory pressure', 'superior with 10 cmH2O positive tele-expiratory pressure', 'superior without positive tele-expiratory pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Maxime Davignon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}