Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-01 @ 6:04 PM
Study NCT ID:
NCT05629832
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2022-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transpulmonary Pressure in Right Ventricle Protection of 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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary vascular resistance (PVR)', 'timeFrame': '3 days', 'description': 'PVR will measured by Swan-Ganz catheter'}, {'measure': 'Pulmonary vascular compliance', 'timeFrame': '3 days', 'description': 'Pulmonary vascular compliance will be calculated using pulmonary artery pressure divided by stroke output measured by Swan-Ganz catheter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Distress Syndrome', 'Acute Cor Pulmonale']}, 'descriptionModule': {'briefSummary': 'To compare the effect between mechanical ventilation strategy guided by transpulmonary pressure and tranditional lung protective ventilation strategy in acute respiratory distress syndrome for right ventricle protection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of invasive mechanical ventilation less than 72 hours;\n* meet the diagnostic criteria of Berlin definition for ARDS;\n* age older than 18\n\nExclusion Criteria:\n\n* esophageal surgery or damage;\n* cardiac surgery;\n* severe bronchopleural fistula;\n* serious arrhythmia; pneumothorax;\n* tricuspid stenosis;\n* heparin allergy;\n* chronic pulmonary heart disease'}, 'identificationModule': {'nctId': 'NCT05629832', 'briefTitle': 'Transpulmonary Pressure in Right Ventricle Protection of ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Transpulmonary Pressure Guided Mechanical Ventilation Strategy for Right Ventricle Protection in Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'Ptp right ventricle protection'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTP group', 'interventionNames': ['Procedure: mechanical ventilation strategy guided by transpulmonary pressure']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'mechanical ventilation strategy guided by transpulmonary pressure', 'type': 'PROCEDURE', 'description': 'Mechanical ventilation parameters adjust guided by transpulmonary pressure monitoring. For pressure assist control or volumn assit control mode; inspiratory pressure or volumn setting needs to maintain Ppeak less than 25 cm H2O; PEEP was set at such a level that expiratory Ptp stayed between 0 and 5 cm H2O.', 'armGroupLabels': ['PTP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Tang', 'role': 'CONTACT', 'email': 'tangxiao0928@163.com', 'phone': '+8613811089795'}], 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao Tang, MD', 'role': 'CONTACT', 'email': 'tangxiao0928@163.com', 'phone': '+86013811089795'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Xiao Tang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}