Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT06498895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2024-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2024-07-06', 'studyFirstSubmitQcDate': '2024-07-06', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung ultrasound score', 'timeFrame': 'first 24 hours'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulmonary Complication', 'Post Operative Complication']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if lung ultrasound score has a strong predictive value for post operative pulmonary complications in living liver transplant recipient', 'detailedDescription': "Back ground :Traditional diagnostic tools such as auscultation or chest x-ray have inferior diagnostic accuracy compared to the gold standard (chest computed tomography), Lung ultrasound is becoming popular in intensive and perioperative care and there is a growing interest to evaluate its role in the detection of postoperative pulmonary pathologies.\n\nMETHODOLOGY Type of Study: observational prospective study\n\n* Study Setting: After obtaining approval from the Research Ethical Committee of Ain Shams University, this study will be conducted in specialized Ain Shams University Hospitals.\n* Study Population : living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in Intensive care unit,will reveal that patients will be divided into two groups according to occurance of lung complications to Pulmonary complications positive ( group that developed pulmonary complications ) and pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "• Study Population: living liver transplant recipient patients post operative in intensive care unit ( 25 patients ), all patients included in this study will be subjected to lung ultrasound score at the pre mentioned times (0,12,24) by most senior expert staff then follow up of patients in intensive care unit will reveal that patients will be divided into two groups according to occurance of lung complications to post operative pulmonary complications positive ( group that developed pulmonary complications ) and post operative pulmonary complications negative (group that didn't develop pulmonary complications ) then sensitivity, specificity and predictive value of lung ultrasound score will be determined", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living liver transplant recipient patients post operative in intensive care unit in first day\n* Age ( Adults 21-60 )\n* Sex ( both genders will be included )\n* ASA 4 liver failure patients .\n\nExclusion Criteria:\n\n* Presence of preoperative chronic lung diseases'}, 'identificationModule': {'nctId': 'NCT06498895', 'briefTitle': 'Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lung Ultrasound Score as Post Operative Predictive Value of Pulmonary Complications in Living Liver Transplant Recipient', 'orgStudyIdInfo': {'id': 'MD102/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'post operative living liver transplant recipient', 'description': 'lung ultrasound score will be done in first 24 hours in intensive care unit for living liver transplant recipient patient', 'interventionNames': ['Radiation: lung ultrasound']}], 'interventions': [{'name': 'lung ultrasound', 'type': 'RADIATION', 'description': 'Lung ultrasound score will be done within one hour of admission,12 hours post admission then 24 hours in intensive care unit,follow up of patients will continue for 72 hours .\n\na complete lung ultrasound evaluation will be performed using low frequency curved probe (2MHz-5MHz) according to the lung ultrasound score . The external lung fields will be examined by longitudinal and transverse plane scans, dividing the surface of the thorax into 12 zones: 6 on the right (anterior: upper R1 and lower R2; lateral; upper R3 and lower R4; posterior: upper R5 and lower R6) and 6 on the left side (front: upper L1 and lower L2; lateral: upper L3 and lower L4; rear: upper L5 and lower L6). LUS assigns 0 points to A lines or \\< 2 separate B lines plus regular sliding; 1 point with lines B ≥ 3 or spaced focal points plus regular sliding; 2 points with coalescing B lines, and 3 points to pulmonary consolidations for each zone with a score ranging from 0 (normal lungs) to 36 (worst case scenario)', 'armGroupLabels': ['post operative living liver transplant recipient']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marina refaat', 'role': 'CONTACT', 'email': 'marina2931994@gmail.com', 'phone': '+01202243566'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}