Ignite Creation Date:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
Study NCT ID:
NCT06062212
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Arterial blood gas analysis, blood routine, liver and kidney function, coagulation, and BNP'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-09-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients successfully weaned from VV-ECMO', 'timeFrame': 'After patients enrolled 60 days', 'description': 'Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO'}], 'secondaryOutcomes': [{'measure': '60-day mortality', 'timeFrame': 'After patients enrolled 60 days', 'description': 'Mortality rate at 60 days of VV-ECMO support'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome', 'Extracorporeal Membrane Oxygenation', 'Mechanical Power', 'Transpulmonary Mechanical Power']}, 'descriptionModule': {'briefSummary': "Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Severe ARDS patients treated with VV-ECMO', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Meet the diagnostic criteria of Berlin's definition for ARDS;\n2. Receiving VV-ECMO support.\n\nExclusion Criteria:\n\n1. Patients had been on high pressure (Ppeak \\>35 cm H2O) and a high fraction of inspired oxygen (FiO2\\>0.8) ventilation for \\>7 days;\n2. Patients had a contraindication to heparinization;\n3. Patients had an irreversible neurological injury;\n4. Patients had severe chronic lung disease with life expectancy \\<6 months."}, 'identificationModule': {'nctId': 'NCT06062212', 'briefTitle': 'Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Effect of Transpulmonary Mechanical Power on the Prognosis of Patients With Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation', 'orgStudyIdInfo': {'id': '2023-KE-926'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transpulmonary pressure group', 'interventionNames': ['Procedure: Transpulmonary pressure']}], 'interventions': [{'name': 'Transpulmonary pressure', 'type': 'PROCEDURE', 'description': 'Use transpulmonary pressure to guide ventilator setting in ECMO for severe ARDS patients.', 'armGroupLabels': ['Transpulmonary pressure group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rui Wang, MD', 'role': 'CONTACT', 'email': 'xuanben1985@163.com', 'phone': '+8618601342030'}], 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yu Zhao, Dr.', 'role': 'CONTACT', 'email': 'xuanben1985@163.com', 'phone': '+8618601342030'}], 'overallOfficials': [{'name': 'Rui Wang, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rui Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}