Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 12:01 PM
Study NCT ID:
NCT07057804
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-30', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of extubation', 'timeFrame': '48 hours post-extubation', 'description': 'Success rate of extubation was recorded'}], 'secondaryOutcomes': [{'measure': 'Diaphragmatic Excursion (DE)', 'timeFrame': 'Within 1 hour prior to extubation', 'description': 'Assessment of diaphragmatic excursion as a predictor of weaning success, measured using ultrasound.'}, {'measure': 'Diaphragmatic Thickening Fraction (DTF)', 'timeFrame': 'Within 1 hour prior to extubation', 'description': 'Assessment of diaphragmatic Thickening Fraction (DTF) as a predictor of weaning success, measured using ultrasound.'}, {'measure': 'Lung Ultrasound Score (LUS)', 'timeFrame': 'Within 1 hour prior to extubation', 'description': 'Evaluation of lung Ultrasound Score (LUS) as a predictor of extubation outcome, measured before extubation using standard lung ultrasound protocols.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung', 'Diaphragm', 'Ultrasound', 'Extubation', 'Weaning', 'Mechanically Ventilation', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the role of lung ultrasound score (LUS), diaphragmatic excursion (DE), and diaphragmatic thickening fraction (DTF) as predictors of successful extubation in mechanically ventilated patients in the intensive care unit (ICU). It also compares these ultrasound-based parameters to traditional weaning criteria.', 'detailedDescription': 'Mechanical ventilation is a necessary life support technology for critically ill patients. The weaning outcome affects the morbidity and mortality of patients when their primary disease improves.\n\nMoreover, lung ultrasonography can be used as an effective measure in the evaluation of lung aeration which is useful during the weaning procedure as it reflect the aeration loss and consequently predict the respiratory distress in the postintubation period, a validated score termed the lung ultrasound score(LUS) can be used to evaluate the loss of lung aeration.\n\nNumerous data measured through diaphragmatic ultrasonography have been recommended for the same purpose, which involve measurement of diaphragmatic muscle movement during inspiration or excursion during the respiratory cycle (DE), and diaphragmatic muscle thickening or diaphragmatic thickening fraction (DTF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study trial was carried out on 90 patients required invasive mechanical ventilation for a minimum of 24 hours and weaning criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who will meet the following weaning criteria undergo Spontaneous Breathing Trial, which include,\n\n * Improvement of disease acute phase which necessitated mechanical ventilation.\n * Stable neurological status.\n * No hemodynamic instability (heart rate ≤ 120/min, systolic blood pressure higher than 90 mmHg and lower than 160 mmHg) in the absence of any vasoactive support therapy.\n * PaO2\\>60 mm Hg or SaO2 ≥ 90% or more with FiO2 ≤ 0.4.\n * Afebrile and there were no significant abnormalities in the electrolyte levels.\n\nExclusion Criteria:\n\n* Hemodynamic unstable patients\n* Patients with severe intracranial disease,\n* Tracheostomy.\n* Severe intensive care unit (ICU) acquired neuromyopathy, with primary unilateral/bilateral absence of diaphragmatic mobility,\n* Patients who had previously failed spontaneous breathing trial (SBT).'}, 'identificationModule': {'nctId': 'NCT07057804', 'briefTitle': 'Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Role of Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'KFSIRB200-202'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients who met the standard clinical weaning criteria underwent bedside lung and diaphragm ultrasound at the end of a successful spontaneous breathing trial (SBT).', 'interventionNames': ['Diagnostic Test: Lung Ultrasound', 'Diagnostic Test: Diaphragm Ultrasound']}], 'interventions': [{'name': 'Lung Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Lung ultrasound was conducted across 12 zones (anterior and posterior) to evaluate aeration and calculate the lung ultrasound score (LUS).', 'armGroupLabels': ['Study group']}, {'name': 'Diaphragm Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Diaphragmatic excursion and thickening fraction were measured on the right hemidiaphragm.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr Elsheikh Governorate', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.', 'investigatorFullName': 'Ahmed Mabrouk Elsayed Ibrahim', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}