Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

Intracranial Aneurysm Clinical Trial

— MS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02090010
• Other study ID #: Modified seldinger
• Status: Unknown status
• Phase: N/A
• First received: March 16, 2014
• Last updated: May 11, 2014
• Start date: April 2014

Study information

• Verified date: March 2014
• Source: Seoul National University Hospital
• Contact: Hee Pyung Park, MD PhD
• Phone: 82-2-2072-2466
• Email: hppark[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 418
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Brain Neoplasm
• Brain Neoplasms
• Cerebrovascular Moyamoya Disease
• Intracranial Aneurysm
• Moyamoya Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University of Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complication rate of subclavian catheterization	Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.	intraoperative
Secondary	primary success rate of subclavian catheterization	Check the number of attempts of needling, guidewire advance, and catheterization in both groups.	intraoperative
Secondary	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