NCT02090010

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 13, 2014

Status Verified

March 1, 2014

Enrollment Period

2.1 years

First QC Date

March 16, 2014

Last Update Submit

May 11, 2014

Conditions

Brain NeoplasmIntracranial AneurysmCerebrovascular Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

  • Major complication rate of subclavian catheterization

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

    intraoperative

Secondary Outcomes (2)

  • primary success rate of subclavian catheterization

    intraoperative

  • Total insertion time

    From skin puctuation until confim the successful catheterization anticipated within 3min

Study Arms (2)

GroupC

ACTIVE COMPARATOR

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

Group MS

EXPERIMENTAL

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

Interventions

Seldinger techniquePROCEDURE

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.

Also known as: thin-wall needle technique
GroupC
Modified Seldinger techniquePROCEDURE

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.

Also known as: guiding sheath-over-the-needle technique
Group MS

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-799, South Korea

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsIntracranial AneurysmMoyamoya Disease

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Arterial DiseasesCerebrovascular DisordersAneurysmVascular DiseasesCardiovascular DiseasesCarotid Artery DiseasesCerebral Arterial DiseasesArterial Occlusive Diseases

Study Officials

  • Hee Pyung Park, MD PhD

    Professor

    STUDY DIRECTOR

  • Eugene Kim, MD

    Clinical Instuctor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Pyung Park, MD PhD

CONTACT

82-2-2072-2466hppark@snu.ac.kr

Eugene Kim, MD

CONTACT

82-2-2072-2469tomomie@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2014

First Posted

March 18, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2016

Last Updated

May 13, 2014

Record last verified: 2014-03

Locations

KR(1)