Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 7:11 AM
Study NCT ID:
NCT05778292
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-18', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-03-18', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung perfusion at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung perfusion distribution Monitored by EIT'}], 'secondaryOutcomes': [{'measure': 'Lung ventilation at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation distribution monitored by EIT'}, {'measure': 'Lung deadspace region at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung deadspace region monitored by EIT'}, {'measure': 'Lung shunt region at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung shunt region monitored by EIT'}, {'measure': 'Lung ventilation/perfusion matching at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation/perfusion matching monitored by EIT'}, {'measure': 'Recirculation at different VV ECMO flows', 'timeFrame': 'up to 24hour', 'description': 'Recirculation at different VV ECMO flows (ECMO flow at 4.5L,3.5L,2.5L,and1.5L)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VV ECMO', 'EIT', 'Lung perfusion'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.', 'detailedDescription': 'This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with respiratory failure supported on VV ECMO', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged ≥ 18 and ≤ 70 years；\n2. Patients supported with VV ECMO for respiratory failure；\n3. Patients are intubated and mechanically ventilated.\n\nExclusion Criteria:\n\n1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;\n2. Patients who did not sign the informed consent form;\n3. Pulmonary embolism;\n4. Pneumothorax;\n5. Medium to plenty of chest water;\n6. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;\n7. Refractory shock;\n8. Severe chronic heart and lung disease has existed in the past;\n9. BMI\\>35 kg/m2;\n10. Intra-abdominal pressure \\>20mmHg.'}, 'identificationModule': {'nctId': 'NCT05778292', 'briefTitle': 'Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT: an Observational Study', 'orgStudyIdInfo': {'id': 'ECMO20221119'}}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaobo Yang, Prof.', 'role': 'CONTACT', 'email': 'want.tofly@aliyun.com', 'phone': '+862785351606'}], 'facility': 'Xiaobo Yang', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xiaobo Yang, prof.', 'role': 'CONTACT', 'email': 'want.tofly@aliyun.com', 'phone': '008602785351606'}, {'name': 'You Shang, prof.', 'role': 'CONTACT', 'email': 'you_shanghust@163.com', 'phone': '008602785351607'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xiaobo Yang, MD', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}