Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-29 @ 5:48 PM
Study NCT ID:
NCT02439151
Status:
COMPLETED
Last Update Posted:
2020-07-01
First Post:
2015-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-29', 'studyFirstSubmitDate': '2015-05-01', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion weaned from VV-ECMO', 'timeFrame': 'After patients randomized grouping 60 days', 'description': 'Respiratory failure was alleviated and then ECMO withdrawal could be considered'}], 'secondaryOutcomes': [{'measure': '60-day mortality', 'timeFrame': 'After patients randomized grouping 60 days', 'description': 'Mortality after patients randomized grouping 60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Extracorporeal Membrane Oxygenation'], 'conditions': ['Respiratory Distress Syndrome, Adult']}, 'descriptionModule': {'briefSummary': 'Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with severe acute respiratory distress syndrome (ARDS). But how to choose mechanical ventilation strategy is still not clear for severe ARDS patients supported by ECMO. Our previous work found that, compared to the traditional "lung rest" strategy, transpulmonary pressure guide new lung ventilation strategy can better maintain lung volume reduction lung collapse, atelectasis occurs. The severe ARDS patients receiving ECMO therapy were randomized divided into a new ventilation strategy group and the conventional ventilation strategy group. The new ventilation strategy is transpulmonary pressure guide ventilator setting method, and the conventional ventilation strategy is Extracorporeal Life Support Organization (ELSO) guide ventilation method. Compare the difference between the two groups of patients in lung injury, and explore the lung protection mechanism of new lung ventilation strategies guided by transpulmonary pressure. Our research group considered that transpulmonary pressure guide new lung ventilation strategy can provide more effective lung protection. And it will be further used in clinical work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARDS cause reversible;\n* Pure oxygen is given, but PaO2/FiO2\\<80;\n* P(A-a)O2\\>600mmHg;\n* Murray scoreā„3.0;\n* pH\\<7.2;\n\nExclusion Criteria:\n\n* peak inspiratory pressure\\>30cmH2O;\n* high FiO2\\>0.8;\n* ventilation\\>7 days;\n* contraindication to heparinization;\n* non-reversible central nervous system injury\n* chronic disease with a short life expectancy'}, 'identificationModule': {'nctId': 'NCT02439151', 'briefTitle': 'New Lung Ventilation Strategies Guided by Transpulmonary Pressure in VV-ECMO for Severe ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'orgStudyIdInfo': {'id': '2014-KE-143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'New Strategy', 'description': 'New Strategy: use transpulmonary pressure guide new lung ventilation strategy in ECMO for severe ARDS patients', 'interventionNames': ['Device: New lung ventilation strategy']}, {'type': 'OTHER', 'label': 'Conventional Strategy', 'description': 'Conventional Strategy: use conventional ventilation strategy (ELSO guide ventilation strategy) in ECMO for severe ARDS patients', 'interventionNames': ['Device: Conventional ventilation strategy']}], 'interventions': [{'name': 'New lung ventilation strategy', 'type': 'DEVICE', 'description': 'New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.', 'armGroupLabels': ['New Strategy']}, {'name': 'Conventional ventilation strategy', 'type': 'DEVICE', 'description': 'Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.', 'armGroupLabels': ['Conventional Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Bing Sun, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rui Wang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rui Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}