Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-01 @ 5:04 PM
Study NCT ID:
NCT05717556
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Success of 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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-02-04', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'factors of internal vein jugular catheterization success', 'timeFrame': 'Baseline (Before catheterization)', 'description': 'neck circumference,'}, {'measure': 'factors of internal vein jugular catheterization success', 'timeFrame': 'Baseline (Before catheterization)', 'description': 'internal juguler vein depth'}, {'measure': 'factors of internal vein jugular catheterization success', 'timeFrame': 'Baseline (Before catheterization)', 'description': 'internal vein diameter'}, {'measure': 'factors of internal vein jugular catheterization success', 'timeFrame': 'Baseline (Before catheterization)', 'description': 'pleth variability index'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['juguler vein catheterization', 'ultrasound guidance', 'pleth variability index'], 'conditions': ['Ultrasound', 'Catheterization', 'Volume Status']}, 'descriptionModule': {'briefSummary': 'Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique.\n\nAlthough Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation.\n\nThe aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-75\n* underwent coronary artery bypass surgery\n\nExclusion Criteria:\n\n* \\<18 years old\n* Hemodynamic instability\n* Use of inotropic agents'}, 'identificationModule': {'nctId': 'NCT05717556', 'briefTitle': 'Success of Internal Jugular Vein Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Factors Affecting Success of First Attempt in Ultrasonography-Guided Internal Jugular Vein Catheterization', 'orgStudyIdInfo': {'id': '2018/12-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'single attempt catheterization', 'description': 'successful catheterization with a single attempt number', 'interventionNames': ['Procedure: Internal Jugular Vein Catheterization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'multiple attempts catheterization', 'description': 'successful catheterization after multiple attempts', 'interventionNames': ['Procedure: Internal Jugular Vein Catheterization']}], 'interventions': [{'name': 'Internal Jugular Vein Catheterization', 'type': 'PROCEDURE', 'description': 'Inserting a cannula into the internal jugular vein', 'armGroupLabels': ['multiple attempts catheterization', 'single attempt catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67600', 'city': 'Kozlu', 'state': 'Esenköy', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Bülent Ecevit University Faculty of Medicine', 'geoPoint': {'lat': 37.63673, 'lon': 41.36877}}, {'zip': '67600', 'city': 'Zonguldak', 'state': 'Kozlu', 'country': 'Turkey (Türkiye)', 'facility': 'Zongulak Bülent Ecevit University', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Bengü Gülhan Köksal', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}