Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04359251
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2020-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different PEEP Settings of COVID-19 Induced ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2020-04-13', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'hemodynamics improvement', 'timeFrame': '20 minutes', 'description': 'MAP were compared among three groups'}], 'primaryOutcomes': [{'measure': 'Respiratory system compliance improvement', 'timeFrame': '20 minutes', 'description': 'the respiratory system compliance was compared among three groups'}], 'secondaryOutcomes': [{'measure': 'Gas echanges improvement', 'timeFrame': '20 minutes', 'description': 'P/Fwere compared among three groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS', 'COVID-19', 'mechanical ventilation', 'PEEP'], 'conditions': ['COVID-19', 'Mechanical Ventilation Pressure High', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '34355001', 'type': 'DERIVED', 'citation': 'Pan C, Lu C, She X, Ren H, Wei H, Xu L, Huang Y, Xia J, Yu Y, Chen L, Du B, Qiu H. Evaluation of Positive End-Expiratory Pressure Strategies in Patients With Coronavirus Disease 2019-Induced Acute Respiratory Distress Syndrome. Front Med (Lausanne). 2021 Jul 20;8:637747. doi: 10.3389/fmed.2021.637747. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This was a multi-center prospective study. All consecutive severe cases of COVID-19 whose PO2/FiO2\\<300mmHg with invasive ventilation admitted to 5 fixed-point receive COVID-19 patients hospitals in Wuhan from 5 March to 15 March 2020 were included. Epidemiological, clinical data, lung mechanics, artery blood gas test and hemodynamics at three methods to titrate PEEP, optimizing oxygenation, optimizing compliance, ARDSnet. The study was approved by the Ethics Committee of Zhongda Hsopital, Southeast University.', 'detailedDescription': 'After PEEP titration, PEEP settings could be set by optimizing oxygenation, optimizing compliance, ARDSnet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19 patients with mechanical ventilation\n* PO2/FIO2\\<300mmHg\n* ages\\>18 years\n\nExclusion Criteria:\n\n* pneumothorax\n* pregnant\n* hemodynamics is unstable'}, 'identificationModule': {'nctId': 'NCT04359251', 'briefTitle': 'Different PEEP Settings of COVID-19 Induced ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Avoiding High PEEP in COVID-19 Induced ARDS: a Multi-center Study', 'orgStudyIdInfo': {'id': 'COVID-19 PEEP titration'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optimizing oxygenation', 'description': 'Best oxygenation during PEEP titration', 'interventionNames': ['Other: Gas exchanges at different PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'Optimizing compliance', 'description': 'Best compliance during PEEP titration', 'interventionNames': ['Other: lung mechanics at different PEEP']}, {'type': 'EXPERIMENTAL', 'label': 'ARDSnet', 'description': 'PEEP settings according to ARDSnet table', 'interventionNames': ['Other: Hemodynamics changes at different PEEP']}], 'interventions': [{'name': 'Gas exchanges at different PEEP', 'type': 'OTHER', 'description': 'Gas exchanges measurement at different PEEP', 'armGroupLabels': ['Optimizing oxygenation']}, {'name': 'lung mechanics at different PEEP', 'type': 'OTHER', 'description': 'lung mechanics measurement at different PEEP', 'armGroupLabels': ['Optimizing compliance']}, {'name': 'Hemodynamics changes at different PEEP', 'type': 'OTHER', 'description': 'Hemodynamics changes measurement at different PEEP', 'armGroupLabels': ['ARDSnet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital, Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Chun C Pan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongda hospital, Southeast University, Jiangsu, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Chun Pan', 'investigatorAffiliation': 'Southeast University, China'}}}}