Subclavian Vein catheterization_Seldinger Vs Modified Seldinger

NCT ID: NCT02090010

Last Updated: 2014-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30

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.

Conditions

Brain Neoplasm; Intracranial Aneurysm; Cerebrovascular Moyamoya Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Seldinger technique

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Modified Seldinger technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

thin-wall needle technique; guiding sheath-over-the-needle technique

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Pyoung Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee Pyung Park, MD PhD

Role: STUDY_DIRECTOR

Professor

Eugene Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Instuctor

Locations

Seoul National University of Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hee Pyung Park, MD PhD

Role: CONTACT

hppark@snu.ac.kr

82-2-2072-2466

Eugene Kim, MD

Role: CONTACT

tomomie@hanmail.net

82-2-2072-2469

Facility Contacts

Hee Pyung Park, MD PhD

Role: primary

hppark@snu.ac.kr

82-2-2072-2466

Eugene Kim, MD

Role: backup

tomomie@hanmail.net

82-2-2072-2469

Other Identifiers

Modified seldinger

Identifier Type: -

Identifier Source: org_study_id