Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
Study NCT ID:
NCT03783468
Status:
WITHDRAWN
Last Update Posted:
2022-03-17
First Post:
2018-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LIght Sedation Pressure Support
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transpulmonary pressure at early stabilization of patient', 'timeFrame': 'when patient is conscious and stable (no modification of ventilator settings) generally within 2 hours', 'description': 'transpulmonary pressure (Paw - Peso \\< 24 cmH2O)'}], 'secondaryOutcomes': [{'measure': 'oxygenation modification', 'timeFrame': 'stabilization of ventilator settings; 1hour after stabilization of ventilator settings', 'description': 'PaO2/FiO2'}, {'measure': 'arterial pressure modification', 'timeFrame': 'stabilization of ventilator settings; 1hour after stabilization of ventilator settings', 'description': 'Mean arterial pressure'}, {'measure': 'Heart rate modification', 'timeFrame': 'stabilization of ventilator settings;1hour after stabilization of ventilator settings', 'description': 'heart rate'}, {'measure': 'vasopressor dose modification', 'timeFrame': 'stabilization of ventilator settings ; 1hour after stabilization of ventilator settings', 'description': 'vasopressor dose in norepinephrine equivalent'}, {'measure': 'acquired neuromyopathy', 'timeFrame': 'ICU discharge, an average 16 days', 'description': 'MRC \\<48/60'}, {'measure': 'muscular volume decrease', 'timeFrame': 'at 24 hours; at day of extubation; ICU discharge, an average 16 days', 'description': 'quadriceps volume assessed by echography'}, {'measure': 'ventilator free days', 'timeFrame': 'during the first 28 days', 'description': 'ventilator free days until day 28'}, {'measure': 'delirium in ICU', 'timeFrame': 'ICU discharge, an average 16 days', 'description': 'CAM-ICU is a valid and reliable delirium assessment tool recommended by the Society of Critical Care Medicine (SCCM) in its 2013 Pain, Agitation and Delirium (PAD) guidelines. the presence of delirium is confirmed in the presence of criteria 1, 2 and 3 or 4.'}, {'measure': 'change of the functional respiratory parameters from baseline at 6 months', 'timeFrame': 'at 6 months', 'description': 'vital capacity, total pulmonary capacity,'}, {'measure': 'PTSD', 'timeFrame': 'at 6 months', 'description': 'post traumatic stress disorder impact of event scale \\> 33 tems are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") and the total score (ranging from 0 to 88)'}, {'measure': 'number of auto extubation', 'timeFrame': 'whatever until ICU discharge, an average 16 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS, Human']}, 'descriptionModule': {'briefSummary': 'Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.\n\nLight sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.\n\nThe goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARDS (Berlin definition)\n* social insurance\n\nExclusion Criteria:\n\n* neuromuscular disorders\n* pregnancy\n* need for muscular paralysis\n* need for deep neurosedation\n* more than 24hrs of artificial ventilation\n* cystic fibrosis'}, 'identificationModule': {'nctId': 'NCT03783468', 'acronym': 'LIPS', 'briefTitle': 'LIght Sedation Pressure Support', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Early LIght Sedation Pressure Support in ARDS Patients', 'orgStudyIdInfo': {'id': '2017_18'}, 'secondaryIdInfos': [{'id': '2018-A01036-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'light sedation pressure support ventilation', 'interventionNames': ['Other: decrease of sedation doses and switch of ventilator settings']}], 'interventions': [{'name': 'decrease of sedation doses and switch of ventilator settings', 'type': 'OTHER', 'description': 'tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation', 'armGroupLabels': ['light sedation pressure support ventilation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geoffrey Ledoux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}