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Subclavian Vein catheterization_Seldinger Vs Modified Seldinger (MS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hee-Pyoung Park, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02090010
First received: March 16, 2014
Last updated: May 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Brain Neoplasm
Intracranial Aneurysm
Cerebrovascular Moyamoya Disease
Procedure: Seldinger technique
Procedure: Modified Seldinger technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Major complication rate of subclavian catheterization [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.


Secondary Outcome Measures:
  • primary success rate of subclavian catheterization [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Check the number of attempts of needling, guidewire advance, and catheterization in both groups.

  • Total insertion time [ Time Frame: From skin puctuation until confim the successful catheterization anticipated within 3min ] [ Designated as safety issue: No ]
    Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.


Estimated Enrollment: 418
Study Start Date: April 2014
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02090010     History of Changes
Other Study ID Numbers: Modified seldinger
Study First Received: March 16, 2014
Last Updated: May 11, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Brain Neoplasms
Intracranial Aneurysm
Moyamoya Disease
Aneurysm
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Cerebrovascular Disorders
Intracranial Arterial Diseases
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014