Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization

August 3, 2020 updated by: Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study

The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

614

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland, 20-081
        • 2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
    • Silesia
      • Opole, Silesia, Poland, 45-401
        • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mechanically ventilated intensive care patients with clinical indications for central venous line placement

Exclusion Criteria:

  • trauma and hematoma at the catheterization site
  • major blood coagulation disorders coincided with active bleeding
  • anatomical abnormalities at the catheterization site
  • infection at the catheterization site
  • age less than 18 years
  • lack of patients or closest relatives consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary catheterization
Real-time ultrasound-guided axillary vein catheterization, in plain technique.
Procedure: Real-time ultrasound-guided central vein catheterization.
Experimental: Jugular catheterization
Real-time ultrasound-guided jugular vein catheterization, out of plain technique.
Procedure: Real-time ultrasound-guided central vein catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure success rate
Time Frame: 24 hours
to define catheterization success rate
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Catheter colonization
Time Frame: 1 month
to assess the incidence of catheter colonization after removal
1 month
Incidence of catheter-related bloodstream infection
Time Frame: 1 month
to assess the incidence of catheter-related bloodstream infection
1 month
Procedure complication rate
Time Frame: 24 hours
to assess the early mechanical complication rate
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Investigators

  • Principal Investigator: Tomasz Czarnik, MD PhD, Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

November 29, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AxillaryJugularUSG-RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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