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Subclavian Vein catheterization_Seldinger Vs Modified Seldinger (MS)

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ClinicalTrials.gov Identifier: NCT02090010
Recruitment Status : Unknown
Verified March 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital

Brief Summary:

Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.

Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.


Condition or disease Intervention/treatment
Brain Neoplasm Intracranial Aneurysm Cerebrovascular Moyamoya Disease Procedure: Seldinger technique Procedure: Modified Seldinger technique

Detailed Description:

The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.

We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Study Start Date : April 2014
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: GroupC
Group C means Control group which use Seldinger technique for subclavian catheterization. The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel.
Procedure: Seldinger technique

The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed.

After that catheter is passed over the guidewire into the vessel.

Other Name: thin-wall needle technique
Experimental: Group MS
Group MS means experimental group which use modified Seldinger technique for subclavian catheterization. The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instatntly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.
Procedure: Modified Seldinger technique
The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instantly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.
Other Name: guiding sheath-over-the-needle technique



Primary Outcome Measures :
  1. Major complication rate of subclavian catheterization [ Time Frame: intraoperative ]
    Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.


Secondary Outcome Measures :
  1. primary success rate of subclavian catheterization [ Time Frame: intraoperative ]
    Check the number of attempts of needling, guidewire advance, and catheterization in both groups.

  2. Total insertion time [ Time Frame: From skin puctuation until confim the successful catheterization anticipated within 3min ]
    Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization

Exclusion Criteria:

  • Patient who does not agree to the study
  • Inflammation or infection on catheterization site
  • Contralateral diaphragmatic dysfunction
  • Anatomic anomalies of subclavian artery or vein/clavicle
  • Previous lung surgical history
  • Patient who has ventriculoperitoneal shunt or chemoport on same side
  • Patient who has pneumo/hemothorax or lung parenchymal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090010


Contacts
Contact: Hee Pyung Park, MD PhD 82-2-2072-2466 hppark@snu.ac.kr
Contact: Eugene Kim, MD 82-2-2072-2469 tomomie@hanmail.net

Locations
Korea, Republic of
Seoul National University of Hospital Recruiting
Seoul, Korea, Republic of, 110-799
Contact: Hee Pyung Park, MD PhD    82-2-2072-2466    hppark@snu.ac.kr   
Contact: Eugene Kim, MD    82-2-2072-2469    tomomie@hanmail.net   
Principal Investigator: Eugene Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Hee Pyung Park, MD PhD Professor
Principal Investigator: Eugene Kim, MD Clinical Instuctor

Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02090010     History of Changes
Other Study ID Numbers: Modified seldinger
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Neoplasms
Moyamoya Disease
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Carotid Artery Diseases
Cerebral Arterial Diseases
Arterial Occlusive Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs