Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT04684069
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2020-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performing time', 'timeFrame': 'First 10 minutes', 'description': 'The time between the insertion of the needle through the skin and insertion of the guidewire into the internal jugular vein.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'First 24 hours', 'description': 'Catheter related complications'}, {'measure': 'Number of neddle pass', 'timeFrame': 'First 10 minutes', 'description': 'a change in needle direction without pulling the entire needle out of the skin'}, {'measure': 'First pass success', 'timeFrame': 'First 10 minutes', 'description': 'Successful catheterization with only one needle pass.'}, {'measure': 'New puncture', 'timeFrame': 'First 10 minutes', 'description': 'Withdraw the needle from the skin to change the puncture site'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrasound', 'catheter', 'long axis', 'short axis', 'pediatrics', 'syringe free'], 'conditions': ['Catheter Complications', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '32174238', 'type': 'BACKGROUND', 'citation': 'Balaban O, Turgut M, Aydin T. Ultrasound-guided supraclavicular brachiocephalic vein catheterization in children: Syringe-free in-plane technique with micro-convex probe. J Vasc Access. 2020 Mar;21(2):241-245. doi: 10.1177/1129729819867221. Epub 2019 Sep 6.'}, {'pmid': '27650385', 'type': 'BACKGROUND', 'citation': 'Matias F, Semedo E, Carreira C, Pereira P. [Ultrasound-guided central venous catheterization - "Syringe-Free" approach]. Rev Bras Anestesiol. 2017 May-Jun;67(3):314-317. doi: 10.1016/j.bjan.2016.08.005. Epub 2016 Sep 17. Portuguese.'}]}, 'descriptionModule': {'briefSummary': 'Internal jugular, subclavian, or femoral veins are often used for central venous catheter (CVC) placement. Regardless of which vein is preferred, the "Seldinger" technique is used most frequently. The most commonly used method with ultrasound is the short-axis out-of-plane approach. The main problem in this method is that the correct needle tip is missed, and it causes some complications by causing posterior wall punctures. The "Syringe-free" technique is first reported by Matias et al. in adults; it is a technique that allows full real-time monitoring of the guidewire insertion into the vein without blood aspiration. It is a great advantage in CVC placement, especially with the long-axis in-plane approach. When the literature is reviewed, no study other than a 12 case study in which brachiocephalic vein catheterization related to CVC placement was performed using this technique in children was found. There is no randomized study comparing the "Syringe-free" Long-Axis In-Plane technique with the classic Short-Axis Out-of-Plane technique in pediatric patients.\n\nThis study compares these two techniques\' efficacy and complication rates in critically ill children requiring CVC placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 3 months, younger than 15 years old\n* Critical illness pediatrics\n\nExclusion Criteria:\n\n* Patients younger than 3 months and older than 15 years,\n* body weight less than 5000 gr,\n* anatomical malformation in the neck,\n* infection at the intervention site,\n* thrombosis'}, 'identificationModule': {'nctId': 'NCT04684069', 'briefTitle': '"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': '"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheter Placement in Critically Ill Children: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'AtaturkCatheter'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'syringe free long axis in-plane', 'interventionNames': ['Device: Long-axis syringe free in-plane']}, {'type': 'SHAM_COMPARATOR', 'label': 'Short axis out-of-plane', 'interventionNames': ['Device: Short-axis out-of-plane']}], 'interventions': [{'name': 'Long-axis syringe free in-plane', 'type': 'DEVICE', 'description': 'Long-axis syringe-free in-plane catheter placement', 'armGroupLabels': ['syringe free long axis in-plane']}, {'name': 'Short-axis out-of-plane', 'type': 'DEVICE', 'description': 'Short-axis out-of-plane catheter placement', 'armGroupLabels': ['Short axis out-of-plane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}