Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04683302
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Guided Internal Jugular Vein Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "coded (e)crf's and anonymized and coded ultrasound clips"}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trial (RCT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'first pass success', 'timeFrame': 'during procedure/surgery', 'description': 'successful entry in internal jugular vein within one skin break and fluid motion'}], 'secondaryOutcomes': [{'measure': 'imaging time', 'timeFrame': 'during procedure/surgery', 'description': 'time from placing USprobe until start needling (in seconds)'}, {'measure': 'needling time', 'timeFrame': 'during procedure/surgery', 'description': 'time from puncturing skin until access in vein (in seconds)'}, {'measure': 'number of skin punctures', 'timeFrame': 'during procedure/surgery', 'description': 'total skin breaks needed before successful entry in vein'}, {'measure': 'number of needle withdrawals', 'timeFrame': 'during procedure/surgery', 'description': 'redirections of needle \\>5mm without needing new skin breaks'}, {'measure': 'number of posterior wall punctures', 'timeFrame': 'during procedure/surgery', 'description': 'puncture of posterior wall of jugular vein'}, {'measure': 'operator satisfaction', 'timeFrame': 'procedure/surgery', 'description': 'satisfaction of operator with visual feedback from US, rated on Likert Scale 1-5 with 1 no satisfaction at all and 5 totally satisfied'}, {'measure': 'needle visibility', 'timeFrame': 'procedure/surgery', 'description': 'visualization of needle during procedure on US screen, rating from good - adequate - poor'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ultrasound', 'internal jugular vein', 'cardiothoracic surgery'], 'conditions': ['Catheter Related Complication', 'Ultrasound; Complications']}, 'referencesModule': {'references': [{'pmid': '34807306', 'type': 'DERIVED', 'citation': 'Scholten HJ, Meesters MI, Montenij LJ, Korsten EHM, Bouwman RA; 3DUI Study group. 3D biplane versus conventional 2D ultrasound imaging for internal jugular vein cannulation. Intensive Care Med. 2022 Feb;48(2):236-237. doi: 10.1007/s00134-021-06579-9. Epub 2021 Nov 22. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate', 'detailedDescription': 'Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4.\n\nFor long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings.\n\nThree dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce.\n\nRecently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures.\n\nThe investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cardiothoracic surgery with need for central venous catheter placement\n* written informed consent\n\nExclusion Criteria:\n\n* no informed consent\n* other site for central line placement (eg subclavian vein)\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT04683302', 'acronym': '3D Givenchy', 'briefTitle': '3D Guided Internal Jugular Vein Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': '3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients', 'orgStudyIdInfo': {'id': '3DJUG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'conventional 2D guided internal jugular vein catheterization', 'interventionNames': ['Device: 2D US catheterization']}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': '3D biplanar guided internal jugular vein catheterization', 'interventionNames': ['Device: 3DUS biplanar catheterization']}], 'interventions': [{'name': '3DUS biplanar catheterization', 'type': 'DEVICE', 'description': 'biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization', 'armGroupLabels': ['intervention']}, {'name': '2D US catheterization', 'type': 'DEVICE', 'description': '2D short axis internal jugular vein catheterization', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5623 EJ', 'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis Eindhoven', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eindhoven University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Harm Scholten', 'investigatorAffiliation': 'Catharina Ziekenhuis Eindhoven'}}}}