Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 4:43 PM
Study NCT ID:
NCT05289960
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Score and Weaning Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extubation success', 'timeFrame': '48 hours', 'description': 'number of participants that do not need for respiratory support neither NIV nor intubation for one week during ICU stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Ultrasound Score', 'Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Objectives: Failure of extubation of patients on mechanical ventilation is one of the common problems in the ICU.\n\nAim of work: To evaluate the validity of lung ultrasound score in prediction of weaning outcomes and post-extubation distress.', 'detailedDescription': 'Methods: A prospective observational study of 50 patients planned for extubation who passed a spontaneous breathing trial, lung ultrasound score and serum level of NT-PRO BNP were done to all patients at end of spontaneous breathing trial, and all patients were followed after extubation and monitored for oxygenation, re-intubation rate, ICU stay, and ICU mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. Patients age \\> 18 years\n\n2\\. Patients intubated and mechanically ventilated for more than 48 hours in the intensive care unit and planned for extubation.\n\nExclusion Criteria:\n\n* 1\\. Patients \\< or =18 years 2. Patients with left ventricular failure\n\n 3\\. Right ventricular failure\n\n 4\\. Pulmonary hypertension\n\n 5\\. Aortic valve disease\n\n 6\\. Hyperthyroidism\n\n 7\\. Tracheostomy'}, 'identificationModule': {'nctId': 'NCT05289960', 'briefTitle': 'Lung Ultrasound Score and Weaning Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Lung Ultrasound Score for Prediction of Weaning Outcome', 'orgStudyIdInfo': {'id': 'MS-490-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients eligible for weaning by spontaneous breathing trial', 'interventionNames': ['Other: lung ultrasound']}, {'type': 'OTHER', 'label': 'non invasive ventilation after weaning', 'interventionNames': ['Other: lung ultrasound']}], 'interventions': [{'name': 'lung ultrasound', 'type': 'OTHER', 'description': 'Lung ultrasound score was done at the end of SBT using curved array ultrasound probe 2-5 MHz, Siemens X300, Korea', 'armGroupLabels': ['non invasive ventilation after weaning', 'patients eligible for weaning by spontaneous breathing trial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11345', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'farouk faris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Mostafa Farouk', 'investigatorAffiliation': 'Cairo University'}}}}