Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT05207267
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2021-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Driving Pressure Guided VT in ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'regional compliance using EIT', 'timeFrame': 'Day 1', 'description': 'regional compliance using EIT'}, {'measure': 'regional ventilation', 'timeFrame': 'Day 1', 'description': 'regional ventilation using EIT'}, {'measure': 'regional perfusion', 'timeFrame': 'Day 1', 'description': 'regional perfusion using EIT'}, {'measure': 'Region-ventilation-delay', 'timeFrame': 'Day 1', 'description': 'Region-ventilation-delay using EIT'}, {'measure': 'driving pressure', 'timeFrame': 'Day 3', 'description': 'measurement as one index of respiratory compliance'}, {'measure': 'the number of regional lung ventilation', 'timeFrame': 'Day 3', 'description': 'regional ventilation measuring by EIT'}, {'measure': 'the number of regional lung perfusion', 'timeFrame': 'Day 3', 'description': 'regional perfusion measuring by EIT'}, {'measure': 'the number of region-ventilation-delay (RVD)', 'timeFrame': 'Day 3', 'description': 'the RVD measuring by EIT'}], 'secondaryOutcomes': [{'measure': 'Value of ventilation-perfusion (V/Q) mismatch', 'timeFrame': 'Day 1', 'description': 'V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).'}, {'measure': 'Value of ventilation-perfusion (V/Q) mismatch', 'timeFrame': 'Day 3', 'description': 'V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated'}, {'measure': 'Value of ventilation-perfusion (V/Q) mismatch', 'timeFrame': 'Day 7', 'description': 'V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated'}, {'measure': 'The Global Inhomogeneity (GI) index', 'timeFrame': 'Day 1', 'description': 'higher values indicating less homogenous ventilation'}, {'measure': 'The Global Inhomogeneity (GI) index', 'timeFrame': 'Day 3', 'description': 'higher values indicating less homogenous ventilation'}, {'measure': 'The Global Inhomogeneity (GI) index', 'timeFrame': 'Day 7', 'description': 'higher values indicating less homogenous ventilation'}, {'measure': 'Blood gas', 'timeFrame': 'Day 1', 'description': 'PaO2'}, {'measure': 'Ventilation free day', 'timeFrame': 'Day 28', 'description': 'ventilation free day in day 28'}, {'measure': '28 day mortality', 'timeFrame': 'Day 28', 'description': 'death in day 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'ventilation and perfusion matching', 'ventilation inhomogeneity'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '38012731', 'type': 'DERIVED', 'citation': 'Yuan X, Zhao Z, Chao Y, Chen D, Chen H, Zhang R, Liu S, Xie J, Yang Y, Qiu H, Heunks L, Liu L. Effects of early versus delayed application of prone position on ventilation-perfusion mismatch in patients with acute respiratory distress syndrome: a prospective observational study. Crit Care. 2023 Nov 27;27(1):462. doi: 10.1186/s13054-023-04749-3.'}]}, 'descriptionModule': {'briefSummary': 'A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.', 'detailedDescription': "Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).\n\nData were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2).\n\nVolume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase，the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged ≥ 18 years old\n2. admitted to intensive care unit with a moderate to severe ARDS\n3. invasive mechanical ventilation\n\nExclusion Criteria:\n\n1. contraindications for prone position ventilation\n2. Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)\n3. New York Heart Association class above II\n4. gave written or witnessed verbal informed consent.\n5. Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)\n6. Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).'}, 'identificationModule': {'nctId': 'NCT05207267', 'briefTitle': 'Driving Pressure Guided VT in ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Safety of Driving Pressure-guided Tidal Volume Setting in ARDS Patients-From the Perspective of EIT', 'orgStudyIdInfo': {'id': 'Ling-driving pressure'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testing arm', 'description': 'ventilated with different VT using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany)', 'interventionNames': ['Device: driving pressure guided tidal volume']}], 'interventions': [{'name': 'driving pressure guided tidal volume', 'type': 'DEVICE', 'description': 'Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position.', 'armGroupLabels': ['testing arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Ling Liu', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ling Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongda Hospital, School of Medicine, Southeast Univerty'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'with in two years after publication', 'ipdSharing': 'YES', 'description': 'by email', 'accessCriteria': 'other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Intensive Care Unit, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}