Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-20 @ 6:48 PM
Study NCT ID:
NCT02083458
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2014-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Infraclavicular Landmark-based Approach to the Axillary Vein
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2014-03-04', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful catheterizations.', 'timeFrame': '24 hours'}, {'measure': 'Procedure success rate depending on physician experience.', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Rate of early complications.', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['critical care', 'catheterization', 'axillary vein'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring.\n\nThe procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava.\n\nThere are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique.\n\nThe primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients admitted to the intensive care unit with indications for central venous catheterization\n\nExclusion Criteria:\n\n* chest wall deformities at the cannulations side\n* major hemostasis disorders\n* infections at the catheterization site\n* age less than 18 years\n* lack of patients consent'}, 'identificationModule': {'nctId': 'NCT02083458', 'briefTitle': 'An Infraclavicular Landmark-based Approach to the Axillary Vein', 'organization': {'class': 'OTHER', 'fullName': 'Uniwersytecki Szpital Kliniczny w Opolu'}, 'officialTitle': 'A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation', 'orgStudyIdInfo': {'id': 'Axillary vein - WCM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'axillary vein catheterization', 'description': 'Catheterization of the axillary vein based on anatomical landmark.', 'interventionNames': ['Procedure: Catheterization of the axillary vein.']}], 'interventions': [{'name': 'Catheterization of the axillary vein.', 'type': 'PROCEDURE', 'armGroupLabels': ['axillary vein catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45-418', 'city': 'Opole', 'state': 'Opole Voivodeship', 'country': 'Poland', 'facility': 'Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}], 'overallOfficials': [{'name': 'Ryszard Gawda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uniwersytecki Szpital Kliniczny w Opolu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior anesthesiologist', 'investigatorFullName': 'Ryszard Gawda, MD', 'investigatorAffiliation': 'Uniwersytecki Szpital Kliniczny w Opolu'}}}}