Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT03812757
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2019-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization
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': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-01', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-19', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correct catheter tip positioning', 'timeFrame': 'Post-procedural x-ray (typically within 24 hours)', 'description': 'Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).'}], 'secondaryOutcomes': [{'measure': 'Mechanical complications within 24 hours', 'timeFrame': 'Within 24 hours after central venous catheterization', 'description': 'Bleeding, cardiac arrhythmias, arterial puncture/cannulation, pneumothorax.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central venous catheter', 'Subclavian vein', 'Supraclavicular fossa ultrasound view'], 'conditions': ['Central Venous Catheter Placement']}, 'referencesModule': {'references': [{'pmid': '34260061', 'type': 'DERIVED', 'citation': 'Adrian M, Kander T, Lunden R, Borgquist O. The right supraclavicular fossa ultrasound view for correct catheter tip positioning in right subclavian vein catheterisation: a prospective observational study. Anaesthesia. 2022 Jan;77(1):66-72. doi: 10.1111/anae.15534. Epub 2021 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.', 'detailedDescription': 'Central venous catheterization is one of the most common procedures within intensive care medicine. Verification of correct catheter tip placement is a primary aspect of safety and quality of central venous catheterization as malposition may lead to life-threatening complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias. Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered gold standard to examine catheter tip location and evaluate for complications such as pneumo- and hemothorax. However, CXR exposes the patient to ionized radiation, requires a considerable amount of time, and is workload-generating for both ICU and radiology staff.\n\nWeber et al has described the use of the right supraclavicular fossa view for real-time ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular vein (IJV) in adults. This approach has subsequently been validated in a clinical study and has also been used for supraclavicular subclavian line insertion. The approach requires use of a microconvex probe, which couples good image resolution and high scanning depth. The use of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion has been described previously, but this is the first description of the supraclavicular fossa ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian CVC placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\>18 years with an indication for CVC placement and under the care of one of three intensivists responsible for the study will be consecutively included in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for central venous catheter placement.\n\nExclusion Criteria:\n\n* Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),\n* Subclavian vein catheterization deemed inappropriate by the operator,\n* Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)'}, 'identificationModule': {'nctId': 'NCT03812757', 'briefTitle': 'Supraclavicular Fossa US View for Catheter Positioning in Right Subclavian Central Venous Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'The Supraclavicular Fossa Ultrasound View for Correct Catheter Positioning in Infraclavicular Right Subclavian Central Venous Catheterization', 'orgStudyIdInfo': {'id': 'CVC positioning'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Supraclavicular fossa US scanning', 'description': 'Following insertion of at least 20 cm of the guidewire into the right subclavian vein, the probe is shifted to the right supraclavicular fossa to scan the right internal jugular vein in order to exclude malposition of the guidewire. The probe is then tilted in a caudal direction to obtain a view of the guidewire within the superior vena cava. Misplaced guidewires will be corrected under real-time ultrasound guidance.', 'interventionNames': ['Diagnostic Test: Supraclavicular fossa US scanning']}], 'interventions': [{'name': 'Supraclavicular fossa US scanning', 'type': 'DIAGNOSTIC_TEST', 'description': 'As previously stated.', 'armGroupLabels': ['Supraclavicular fossa US scanning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skånes universitetssjukhus', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Ola Borgquist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skane University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ola Borgquist', 'investigatorAffiliation': 'Skane University Hospital'}}}}