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Subclavian Vein catheterization_Seldinger Vs Modified Seldinger (MS)

Primary Purpose

Brain Neoplasm, Intracranial Aneurysm, Cerebrovascular Moyamoya Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Seldinger technique
Modified Seldinger technique
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Neoplasm

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University of HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

GroupC

Group MS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Major complication rate of subclavian catheterization
Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.

Secondary Outcome Measures

primary success rate of subclavian catheterization
Check the number of attempts of needling, guidewire advance, and catheterization in both groups.
Total insertion time
Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.

Full Information

First Posted
March 16, 2014
Last Updated
May 11, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02090010
Brief Title
Subclavian Vein catheterization_Seldinger Vs Modified Seldinger
Acronym
MS
Official Title
Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasm, Intracranial Aneurysm, Cerebrovascular Moyamoya Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GroupC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group MS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Seldinger technique
Other Intervention Name(s)
thin-wall needle technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Modified Seldinger technique
Other Intervention Name(s)
guiding sheath-over-the-needle technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major complication rate of subclavian catheterization
Description
Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
primary success rate of subclavian catheterization
Description
Check the number of attempts of needling, guidewire advance, and catheterization in both groups.
Time Frame
intraoperative
Title
Total insertion time
Description
Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.
Time Frame
From skin puctuation until confim the successful catheterization anticipated within 3min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Eugene Kim, MD
Phone
82-2-2072-2469
Email
tomomie@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Pyung Park, MD PhD
Organizational Affiliation
Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Organizational Affiliation
Clinical Instuctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University of Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Pyung Park, MD PhD
Phone
82-2-2072-2466
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD
Phone
82-2-2072-2469
Email
tomomie@hanmail.net
First Name & Middle Initial & Last Name & Degree
Eugene Kim, MD

12. IPD Sharing Statement

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Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

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