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Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Central Venous Catheterization

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ClinicalTrials.gov Identifier: NCT01902355
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
Deok Man Hong, Seoul National University Hospital

Brief Summary:
The purpose of this study is to compare two needle insertion techniques(Seldinger vs. modified Seldinger technique) on success rate and complications during central venous catheterization.

Condition or disease Intervention/treatment Phase
Complications of Central Venous Catheterization Procedure: modified Seldinger technique Procedure: Seldinger technique Not Applicable

Detailed Description:

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.

Because 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.

Seldinger 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hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn.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 The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

When 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.

When 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.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 272 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 Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: modified Seldinger 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.
Procedure: modified Seldinger technique
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.

Active Comparator: Seldinger technique
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.
Procedure: Seldinger technique
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.




Primary Outcome Measures :
  1. number of attempts of guidewire advance [ Time Frame: after internal jugular vein puncture ]
    after desired vessel is punctured guidewire is advanced through the lumen of the needle or guiding sheath


Secondary Outcome Measures :
  1. complications of internal jugular vein central catheterization [ Time Frame: after central catheter placement ]

    any complications including arterial puncture, hematoma of skin and subcutaneous tissue, pneumothorax, hemothorax

    - evaluate with ultrasonography and compare with pre-catheterization image




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient scheduled for surgery and internal jugular vein central catheterization

Exclusion Criteria:

  • Patient who doesn't agree to the study
  • Catheterization site inflammation
  • Contralateral diaphragmatic dysfunction
  • Anatomic anomalies of carotid artery or vein
  • Previous neck surgical history
  • Recent(less than 1 month) right internal jugular vein central catheterization

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): NCT01902355


Locations
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Korea, Republic of
Seoul National University of Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Deok Man Hong, M.D., Ph. D. Seoul National University Hospital
Study Director: Tae Kyong Kim, M.D. Seoul National University of Hospital

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Responsible Party: Deok Man Hong, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01902355     History of Changes
Other Study ID Numbers: modifiedSeldinger
H1305617491 ( Other Identifier: SNUH )
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Deok Man Hong, Seoul National University Hospital:
Central Venous Catheterization