Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-04 @ 7:30 AM
Study NCT ID:
NCT04463303
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of B-lines in lung ultrasound and its accuracy in diagnosis of weaning induced pulmonary oedema', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Detecting the Number of B-lines in Lung Ultrasound and Its Accuracy in Diagnosis of Weaning Induced Pulmonary Oedema']}, 'descriptionModule': {'briefSummary': 'The aim of the work is to\n\n1. Assess the incidence of weaning induced pulmonary adema(WIPO).\n2. Assess the risk factors of WIPO.\n3. Evaluate the role of lung ultrasound in detecting WIPO during spontenous breathing trial(SBT).\n4. Detect the threshold of B-line increase (Delta-B-lines) that provided the best diagnostic accuracy of WIPO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study will include patients on mechanical ventilation who will be suitable for spontaneous breathing trial (SBT).\n\nExclusion Criteria:\n\n* Patients with poor lung ultrasound window, history of cardiomyopathy, significant valvular disease (aortic or mitral insufficiency of grade ≥ 2, mild or severe aortic and mitral stenosis) will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04463303', 'briefTitle': 'The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of Lung Ultrasound in The Diagnosis of Weaning -Induced Pulmonary Edema', 'orgStudyIdInfo': {'id': 'LULTRASOUND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'patient who will develop weaning induced pulmonary adema', 'interventionNames': ['Other: lung ultrasound']}, {'label': 'group 2', 'description': 'patient who will nor develop weaning induced pulmonary adema', 'interventionNames': ['Other: lung ultrasound']}], 'interventions': [{'name': 'lung ultrasound', 'type': 'OTHER', 'description': 'patient with or without weaning induced pulmonary adema', 'armGroupLabels': ['group 1', 'group 2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Internal Medicine', 'investigatorFullName': 'Dina Ali Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}