Subclavian Vein catheterization_Seldinger Vs Modified Seldinger (MS)

Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique

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.

Study Overview

• Status: Unknown
• Conditions: Brain Neoplasm; Intracranial Aneurysm; Cerebrovascular Moyamoya Disease
• Intervention / Treatment: 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
• Enrollment (Anticipated): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
• Study Contact Backup: Name: Eugene Kim, MD; Phone Number: 82-2-2072-2469; Email: tomomie@hanmail.net

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-799
    • Recruiting
    • Seoul National University of Hospital
    • Contact: Hee Pyung Park, MD PhD; Phone Number: 82-2-2072-2466; Email: hppark@snu.ac.kr
    • Contact: Eugene Kim, MD; Phone Number: 82-2-2072-2469; Email: tomomie@hanmail.net
    • Principal Investigator: Eugene Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: guiding sheath-over-the-needle technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complication rate of subclavian catheterization	Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary success rate of subclavian catheterization	Check the number of attempts of needling, guidewire advance, and catheterization in both groups.	intraoperative
Total insertion time	Check the total insertion time from skin puncture to confirm the successful catheterization via venous aspiration though catheter lumen.	From skin puctuation until confim the successful catheterization anticipated within 3min

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Hee Pyung Park, MD PhD, Professor; Principal Investigator: Eugene Kim, MD, Clinical Instuctor

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: March 16, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Brain Neoplasms; Moyamoya Disease; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Modified seldinger