Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-02 @ 3:23 AM
Study NCT ID:
NCT07062068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided BCV and IJV in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cannulation failure rate', 'timeFrame': 'Baseline', 'description': 'Failure to cannulate selected vein at 1st attempt'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Comparative Study Between Ultrasound-Guided Brachiocephalic Vein and Internal Jugular Vein Cannulation in Mechanically Ventilated ICU Patients'], 'conditions': ['Ultrasound-Guided Vascular Access', 'ICU Patients']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized clinical trial aiming to compare the success rate, complications, and insertion time between ultrasound-guided brachiocephalic vein (BCV) and internal jugular vein (IJV) cannulation in mechanically ventilated patients in the intensive care unit (ICU). The goal is to determine whether BCV access offers a safer or more effective alternative in critically ill patients requiring central venous catheter placement.', 'detailedDescription': 'Central venous cannulation is a common and essential procedure in the management of critically ill patients, especially those requiring mechanical ventilation. Traditionally, the internal jugular vein (IJV) has been the preferred site. However, the brachiocephalic vein (BCV) has recently gained attention due to its potentially favorable anatomical location and reduced complication rates.\n\nThis study is designed to compare the outcomes of ultrasound-guided cannulation of the BCV versus the IJV, focusing on parameters such as success rate of insertion on first attempt, total cannulation time, and incidence of complications such as arterial puncture, pneumothorax, or hematoma formation. The study will be conducted on adult patients admitted to the ICU and undergoing mechanical ventilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n100 patients with age between ( 18 - 50 years old ) ventilated in ICU with need central venous access , with physical status II or III according to ASA classification .\n\nExclusion Criteria:\n\n* refusal of relatives of patients\n* Any contraindication of Central venous line insertion as thrombocytopenia , coagulopathy …. Etc\n* any suspected or documented thrombus inside vein\n* any congenital or acquired musculo-skeletal deformities of neck or clavicle\n* any active infections or signs of inflammation over insertion site\n* any previous procedures performed at the cannulation site'}, 'identificationModule': {'nctId': 'NCT07062068', 'briefTitle': 'Ultrasound-Guided BCV and IJV in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparative Study Between Ultrasound-Guided Brachiocephalic Vein and Internal Jugular Vein Cannulation in Mechanically Ventilated ICU Patients', 'orgStudyIdInfo': {'id': 'SU-BCV-IJV-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'candidates for BCV cannulation', 'interventionNames': ['Procedure: ultrasound guided Brachiocephalic vein and internal jugular vein cannulation in mechanically ventilated ICU patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'candidates for IJV cannulation', 'interventionNames': ['Procedure: ultrasound guided Brachiocephalic vein and internal jugular vein cannulation in mechanically ventilated ICU patients']}], 'interventions': [{'name': 'ultrasound guided Brachiocephalic vein and internal jugular vein cannulation in mechanically ventilated ICU patients', 'type': 'PROCEDURE', 'description': 'For Arm ( candidates for BCV cannulation ) :\n\nby ultrasound guided we insert Central venous catheter in BCV under complete aseptic condition For Arm ( candidates for IJV cannulation ) by ultrasound guided we insert central venous catheter in IJV under complete aseptic conidtion we do comparison between the 2 arms as regard : 1st pass success rate , complications and failure rate in ventilated patient in ICU .', 'armGroupLabels': ['candidates for BCV cannulation', 'candidates for IJV cannulation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hasnaa mohey ibrahim, resident doctor', 'role': 'CONTACT', 'email': 'hasnaa.mohy@med.sohag.edu.eg', 'phone': '0201156950052'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at department of anesthesia and ICU', 'investigatorFullName': 'Hasnaa Mohy Ibrhim', 'investigatorAffiliation': 'Sohag University'}}}}