Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-24 @ 4:53 PM
Study NCT ID:
NCT03077802
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
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']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of attempts of needle advance for successful venous puncture', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'number of attempts of needle advance (number of needling attempt)'}], 'secondaryOutcomes': [{'measure': 'incidence of arterial puncture', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of arterial puncture during internal jugular vein catheterization'}, {'measure': 'incidence of local hematoma', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of jugular venous hematoma during internal jugular vein catheterization'}, {'measure': 'incidence of pneumothorax', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of pneumothorax during internal jugular vein'}, {'measure': 'incidence of hemothorax', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of hemothorax during internal jugular vein'}, {'measure': 'Time to successful jugular venous catheterization', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of hemothorax during internal jugular vein (overall procedure time)'}, {'measure': 'number of attempts of needle advance', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'number of attempts of needle advance'}, {'measure': 'number of attempts of catheter advance', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'number of attempts of needle advance (only in modified Seldinger group)'}, {'measure': 'incidence of successful central venous catheterization', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'incidence of successful central venous catheterization (success defined as completion of catheterization within three attempts of needle advance)'}, {'measure': 'grade of resistance during dilator insertion', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'grade of resistance during dilator insertion (grade 1: easy, grade 2: moderate, grade 3: difficult, use of blade for skin incision'}, {'measure': 'number of attempts of guidewire advance', 'timeFrame': '5 min after internal jugular vein catheterization', 'description': 'number of attempts of guidewire advance through the lumen of needle or guidewire sheath after desired vessel is punctured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Seldinger technique', 'Modified Seldinger technique', 'Complication', 'Success rate'], 'conditions': ['Catheterization, Central Venous']}, 'referencesModule': {'references': [{'pmid': '33762662', 'type': 'DERIVED', 'citation': "Yoon HK, Hur M, Cho H, Jeong YH, Lee HJ, Yang SM, Kim WH. Effects of practitioner's experience on the clinical performance of ultrasound-guided central venous catheterization: a randomized trial. Sci Rep. 2021 Mar 24;11(1):6726. doi: 10.1038/s41598-021-86322-y."}]}, 'descriptionModule': {'briefSummary': 'The investigators intend to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by a prospective, randomized, controlled study. The investigators are planning to compare both techniques in both experienced (anesthesiologist board member) and non-experienced practitioners (first and second-grade resident).', 'detailedDescription': 'Unintended arterial puncture and local hematoma formation are the most common complications during internal jugular vein central venous catheterization. Other serious complications like pseudoaneurysm, arteriovenous fistula, arterial dissection, thrombosis, embolism are also possible. These complications mostly occur by mechanical trauma or injury when advancing needle back and forth to puncture internal jugular vein. Placement of guidewire or dilator can also cause mechanical trauma or injury around the vessel.\n\nBecause internal jugular vein collapses easily during needle advance, anterior and posterior wall of the vessel can be punctured simultaneously. Posterior wall puncture can increase the risk of complications of the catheterization. Delicate puncture of the vessel and stable fixation of the needle after puncture are important to reduce overall number of catheterization attempts, increase success rate, reduce complications.\n\nSeldinger technique(thin-wall needle technique) is commonly used procedure to obtain safe access to central vein. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.\n\nWhen using Seldinger technique, it is important to fix the needle firmly with hand until the guidewire is placed into the vessel lumen. If hand fixation is not stable, needle tip can migrate from the lumen, can pierce the vessel wall, and carotid artery puncture, and local hematoma formation might occur. Even if there is no evidence of complications, when blood regurgitation fails, overall number of vessel puncture attempts would increase and it is expected that rate of complications of the catheterization would increase.\n\nWhen using modified Seldinger technique, guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively in early step of the catheterization. Therefore, it is expected that stability of the fixation improves, success rate of the catheterization increase, and complications of the catheterization decrease. But there is no high level of evidence yet, and still decision to use which technique is based on experience of the operator.\n\nThe investigators are going to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by prospective, randomized, controlled study.\n\nIn addition, any difference in success rate and complications between the two techniques may be different depending on the experience of the practitioners. Therefore, the investigators also plan to compare the two techniques between experienced and non-experienced practitioners.\n\nThe success rate and complications between the two techniques may also be different depending on the long and short-axis techniques. As subgroup analyses, we intend to investigate whether there is a difference between Seldinger and modified Seldinger technique according to the experience of the operator or long or short axis approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient scheduled for surgery and internal jugular vein central catheterization\n\nExclusion Criteria:\n\n* Patient who doesn't agree to the study\n* Catheterization site inflammation\n* Contralateral diaphragmatic dysfunction\n* Anatomic anomalies of carotid artery or vein\n* Previous neck surgical history\n* Recent (less than 1 month) right internal jugular vein central catheterization"}, 'identificationModule': {'nctId': 'NCT03077802', 'briefTitle': 'Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique', 'orgStudyIdInfo': {'id': '1506-126-684'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Seldinger technique, Experienced group', 'description': 'Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques.', 'interventionNames': ['Other: Modified Seldinger technique, Experienced group', 'Other: Long-axis technique', 'Other: Short-axis technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Seldinger technique, Experienced group', 'description': 'Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques.', 'interventionNames': ['Other: Seldinger technique, Experienced group', 'Other: Long-axis technique', 'Other: Short-axis technique']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Seldinger technique, Inexperienced group', 'description': 'Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques.', 'interventionNames': ['Other: Modified Seldinger technique, Inexperienced group', 'Other: Long-axis technique', 'Other: Short-axis technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Seldinger technique, Inexperienced group', 'description': 'Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques.', 'interventionNames': ['Other: Seldinger technique, Inexperienced group', 'Other: Long-axis technique', 'Other: Short-axis technique']}], 'interventions': [{'name': 'Modified Seldinger technique, Experienced group', 'type': 'OTHER', 'description': 'This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.', 'armGroupLabels': ['Modified Seldinger technique, Experienced group']}, {'name': 'Seldinger technique, Experienced group', 'type': 'OTHER', 'description': 'This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.', 'armGroupLabels': ['Seldinger technique, Experienced group']}, {'name': 'Modified Seldinger technique, Inexperienced group', 'type': 'OTHER', 'description': 'This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.', 'armGroupLabels': ['Modified Seldinger technique, Inexperienced group']}, {'name': 'Seldinger technique, Inexperienced group', 'type': 'OTHER', 'description': 'This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.', 'armGroupLabels': ['Seldinger technique, Inexperienced group']}, {'name': 'Long-axis technique', 'type': 'OTHER', 'description': 'Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.', 'armGroupLabels': ['Modified Seldinger technique, Experienced group', 'Modified Seldinger technique, Inexperienced group', 'Seldinger technique, Experienced group', 'Seldinger technique, Inexperienced group']}, {'name': 'Short-axis technique', 'type': 'OTHER', 'description': 'Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.', 'armGroupLabels': ['Modified Seldinger technique, Experienced group', 'Modified Seldinger technique, Inexperienced group', 'Seldinger technique, Experienced group', 'Seldinger technique, Inexperienced group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Won Ho Kim, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}