Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:00 PM
Study NCT ID:
NCT05886556
Status:
UNKNOWN
Last Update Posted:
2023-06-26
First Post:
2023-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-22', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic data checklist', 'timeFrame': 'immediately after ICU admission', 'description': 'Data of CT chest ,lung ultrasound and chest radiography in diagnosis of ARDS .'}], 'secondaryOutcomes': [{'measure': 'success rate', 'timeFrame': 'within 24 hours after weaning', 'description': 'compared the success of both methods in terms of reintubation or not for those patients'}, {'measure': 'lung ultrasound as a predictor for weaning', 'timeFrame': 'immediately before weaning', 'description': 'evaluate the scoring of lung aeration'}, {'measure': 'diaphragmatic ultrasound as a predictor for weaning', 'timeFrame': 'immediately before weaning', 'description': 'diaphragmatic thickness and excursion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung ultrasound, acute respiratory distress syndrome'], 'conditions': ['of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the validity of lung ultrasound compared to CT chest and chest radiograph for diagnosis of ARDS and prediction of successful weaning from mechanical ventilation in those patients compared to traditional methods.', 'detailedDescription': '57 patients will be diagnosed as ARDS by CT chest and clinical criteria, then will be compared between the findings by lung ultrasound and chest radiograph to detect the sensitivity of both imaging to CT chest as gold standard in diagnosis of ARDS patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients highly suspected to be ARDS admitted to ICU', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients or legal guardian's consent .All patients with suspicious criteria of acute respiratory distress syndrome .Hemodynamically stable in the absence or minimal of vasopressors.\n\nExclusion Criteria:\n\nPregnant women. patients with traumatic lung injury or pneumothorax. surgical dressings over the right lower rib cage which would preclude ultrasound examination. presence of ascites. presence of lung collapse, fibrosis, or pleural effusion.\n\n-presence of any mass or mechanical factor in the chest or the abdomen interfering with the diaphragmatic mobility."}, 'identificationModule': {'nctId': 'NCT05886556', 'briefTitle': 'Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Validity of Lung Ultrasound in Diagnosis of Acute Respiratory Distress Syndrome and Prediction of Successful Weaning From Mechanical Ventilation in Those Patients', 'orgStudyIdInfo': {'id': '8053'}}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'marwa m medhat, MD', 'role': 'CONTACT', 'phone': '01002828937'}], 'facility': 'Faculty of Medicine,Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Marwa M Medhat, M.D', 'role': 'CONTACT', 'email': 'Medhatmarwa9@gmail.com', 'phone': '0552330832'}], 'overallOfficials': [{'name': 'mona elharisy, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'zagazig university faculty of human medicine'}, {'name': 'Marwa M Medhat, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'zagazig university faculty of human medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecture of anesthesia and surgical intensive care (Principal Investigator)', 'investigatorFullName': 'Marwa Mohamed Medhat', 'investigatorAffiliation': 'Zagazig University'}}}}