Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-26 @ 3:45 PM
Study NCT ID:
NCT05140668
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2021-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Supraclavicular And Infraclavicular Approach For Right Subclavian Venous Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-05-26', 'releaseDate': '2022-07-10'}], 'estimatedResultsFirstSubmitDate': '2022-07-10'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-26', 'studyFirstSubmitDate': '2021-11-14', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare between the Supraclavicular and infraclavicular approach in right subclavian vein catheterization as regard accessibility sonar guided and number of punctures which is needed and the time of the procedure', 'timeFrame': '7 months', 'description': "After successful venous puncture, catheterization was attempted with the Seldinger's technique The guidewire and dilator were inserted to a depth of 10-15 cm and to the depth of venous puncture, respectively.\n\nWe considered an attempt at catheterization as 'failed' if successful catheterization was not achieved within 3 min or If an anesthetist failed to catheterize the patient successfully within three attempts in 210 patients"}], 'secondaryOutcomes': [{'measure': 'to compare complications which result from supraclavicular or approaches for right subclavian venous catheter insertion', 'timeFrame': '7 months', 'description': 'monitoring of complications which can result from any of the two approaches e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax it can monitored Clinically , blood gases and Chest X-Ray in 210 patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Line Complication']}, 'referencesModule': {'references': [{'pmid': '22099008', 'type': 'BACKGROUND', 'citation': 'Beheshti MV. A concise history of central venous access. Tech Vasc Interv Radiol. 2011 Dec;14(4):184-5. doi: 10.1053/j.tvir.2011.05.002.'}, {'pmid': '16204277', 'type': 'BACKGROUND', 'citation': 'Konner K. History of vascular access for haemodialysis. Nephrol Dial Transplant. 2005 Dec;20(12):2629-35. doi: 10.1093/ndt/gfi168. Epub 2005 Oct 4.'}, {'pmid': '22307320', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.'}, {'pmid': '26595049', 'type': 'BACKGROUND', 'citation': 'Suess EM, Pinsky MR. Hemodynamic Monitoring for the Evaluation and Treatment of Shock: What Is the Current State of the Art? Semin Respir Crit Care Med. 2015 Dec;36(6):890-8. doi: 10.1055/s-0035-1564874. Epub 2015 Nov 23.'}]}, 'descriptionModule': {'briefSummary': "A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a larg central vein for a multitude of indications in major elective surgeries and ICU patients and now it's now with notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site to decreases the complications", 'detailedDescription': "A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium.for a multitude of indications including; total parenteral nutrition administration dialysis, plasmapheresis , medication administration, hemodynamic monitoring and to facilitate further complex interventions such as transvenous pacemaker placement inserted with Seldinger's technique. A notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site owing to associated decreases in complications e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax and catheterization failure and an increase in first-pass success."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria adult patients aged 20-79 y old who required central venous catheterization for : total parenteral nutrition administration dialysis plasmapheresis medication administration hemodynamic monitoring\n\nExclusion Criteria:\n\n* Patient refusel Irritable patient Infection at the puncture site medical devices (chemoport, pacemaker,etc.) at the puncture site. right subclavian venous thrombosis haemostatic disorders current anticoagulant medication prescriptions previous history of surgery that might distort the anatomy of the right subclavian vein.'}, 'identificationModule': {'nctId': 'NCT05140668', 'briefTitle': 'Comparison Between Supraclavicular And Infraclavicular Approach For Right Subclavian Venous Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Comparison Between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients', 'orgStudyIdInfo': {'id': 'soh-med-21-11-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supraclavicular central venous catheterization approach group', 'description': 'supraclavicular central venous catheterization group catheter is inserted in supraclavicular fossa (an indentation immediately above the clavicle) with a long-axis in plane approach', 'interventionNames': ['Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infraclavicular central venous catheterization approach group', 'description': 'infraclavicular central venous catheterization group catheter is inserted in infraclavicular fossa (an indentation, immediately below the clavicle, above the third rib and between the deltoid muscle laterally and medioclavicular line medially) with a short-axis out-of-plane approach', 'interventionNames': ['Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization']}], 'interventions': [{'name': 'Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization', 'type': 'DEVICE', 'description': 'Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization', 'armGroupLabels': ['Infraclavicular central venous catheterization approach group', 'Supraclavicular central venous catheterization approach group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients', 'investigatorFullName': 'Maha Hamed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-10', 'type': 'RELEASE'}, {'date': '2023-05-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Maha Hamed Mohamed, Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients, Sohag University'}}}}