Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-10 @ 1:36 AM
Study NCT ID:
NCT01966861
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2013-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2013-10-15', 'studyFirstSubmitQcDate': '2013-10-17', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory distress requiring re-intubation or non-invasive ventilation', 'timeFrame': '48hours'}], 'secondaryOutcomes': [{'measure': '28-day mortality', 'timeFrame': '28 days'}, {'measure': 'Hospital Mortality', 'timeFrame': 'Hospital death/discharge (up to 60 days)'}, {'measure': 'Adverse events', 'timeFrame': '48h', 'description': 'Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'weaning', 'acute respiratory failure', 'weaning failure', 'lung ultrasound'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanically ventilated \\>48h\n\nExclusion Criteria:\n\n* Moderate/Severe COPD\n* Spinal cord lesion\n* Neuromuscular disease (previous)\n* Lung fibrosis\n* Tracheostomy\n* Heart failure (EF\\<50%)\n* Lung/pleural cancer\n* inadequate "window"for LUS'}, 'identificationModule': {'nctId': 'NCT01966861', 'acronym': 'WEANLUS-BR', 'briefTitle': 'Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)', 'organization': {'class': 'OTHER', 'fullName': "D'Or Institute for Research and Education"}, 'officialTitle': 'Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)', 'orgStudyIdInfo': {'id': 'IDOR-03-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care', 'description': "Weaning as protcolised by the units' daily practice (SBT)"}, {'type': 'EXPERIMENTAL', 'label': 'Weaning guided by lung ultrasound', 'description': 'Predictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis)', 'interventionNames': ['Other: weaning guided by LUS (lung ultrasound)']}], 'interventions': [{'name': 'weaning guided by LUS (lung ultrasound)', 'type': 'OTHER', 'description': 'Predictive early signs of respiratory distress are assessed by lung ultrasound (LUS score \\>14) and if present will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis, antibiotics when required \\[CPIS\\>6\\], hemglobin\\>8g/dl triggers transfusion)', 'armGroupLabels': ['Weaning guided by lung ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20230-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': "D'OR Institute for Research and Education", 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Jorge IF Salluh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "D'Or Institute for Research and Education"}, {'name': 'Luiz M Malbouisson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Fabiola Prior, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Julio Neves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital da Bahia'}, {'name': 'Jean-Jacques Rouby, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Paris University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "D'Or Institute for Research and Education", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sirio-Libanes', 'class': 'OTHER'}, {'name': 'University of Sao Paulo', 'class': 'OTHER'}, {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jorge Salluh', 'investigatorAffiliation': "D'Or Institute for Research and Education"}}}}