Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-25 @ 12:37 PM
Study NCT ID:
NCT02859194
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2016-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D018192', 'term': 'Lymphangioleiomyomatosis'}, {'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008203', 'term': 'Lymphangiomyoma'}, {'id': 'D018190', 'term': 'Neoplasm, Lymphatic Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054973', 'term': 'Perivascular Epithelioid Cell Neoplasms'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-15', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-08-03', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'arterial blood oxygen partial pressure (PaO2)', 'timeFrame': '5 min after jugular catheter flow 0ml/min'}, {'measure': 'arterial blood oxygen partial pressure (PaO2)', 'timeFrame': '5 min after jugular catheter flow 500 ml/min'}, {'measure': 'arterial blood oxygen partial pressure (PaO2)', 'timeFrame': '5 min after jugular catheter flow 1,000ml/min'}, {'measure': 'arterial blood oxygen partial pressure (PaO2)', 'timeFrame': '5 min after jugular catheter flow 1,500ml/min'}], 'secondaryOutcomes': [{'measure': 'venous blood oxygen partial pressure (PvO2)', 'timeFrame': '5 min after jugular catheter flow 0ml/min'}, {'measure': 'venous blood oxygen partial pressure (PvO2)', 'timeFrame': '5 min after jugular catheter flow 500 ml/min'}, {'measure': 'venous blood oxygen partial pressure (PvO2)', 'timeFrame': '5 min after jugular catheter flow 1,000ml/min'}, {'measure': 'venous blood oxygen partial pressure (PvO2)', 'timeFrame': '5 min after jugular catheter flow 1,500ml/min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Interstitial Pulmonary Fibrosis ARDS', 'COPD (Chronic Obstructive Pulmonary Disease)', 'Bronchiectasis', 'Lymphangioleiomyomatosis', 'Primary Pulmonary Hypertension', 'ARDS (Acute Respiratory Distress Syndrome)']}, 'descriptionModule': {'briefSummary': 'ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure patients. V-A ECMO can also be used during lung transplantation, substitution of cardiopulmonary bypass, which can show sufficient performance during operation and better postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral artery, there is a pro blem of differential hypoxia which might influence coronary artery and head vessels. In this prospective study, the investigators are planning to put another ECMO catheter into internal jugular vein which takes a role of left to right shunt, to mitigate the hypoxia of coronary artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. scheduled for double lung transplantation\n\nExclusion Criteria:\n\n1. patients who have history of coronary artery occlusive disease\n2. patients with arrhythmia'}, 'identificationModule': {'nctId': 'NCT02859194', 'briefTitle': 'The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2016-0124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Veno-veno-arterial ECMO group', 'interventionNames': ['Procedure: Veno-veno-arterial ECMO']}], 'interventions': [{'name': 'Veno-veno-arterial ECMO', 'type': 'PROCEDURE', 'armGroupLabels': ['Veno-veno-arterial ECMO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}