Ultrasound-guided Catheterization of the Axillary Vein

May 8, 2016 updated by: Tomasz Czarnik, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

Real-time Ultrasound-guided Catheterization of the Axillary Vein in the Intensive Care Unit

The central venous catheterization (central line placement) is the common procedure performed in the intensive care unit. This procedure is performed by percutaneous puncture of so called 'the central vein' and than advancement of the catheter over the guidewire (Seldinger technique). The tip of the catheter is left in the superior vena cava in the vicinity of the right atrium of the heart. Central veins are large veins in the human body passing the blood into the heart.

Typical, clinical indications for the central line placement in the intensive care unit are hemodynamic monitoring, volume monitoring, administration of medications, long-term total parenteral nutrition, access for renal replacement therapy, difficult peripheral catheterization.

There are two methods of the central venous catheterization in terms of visualization. First and older is the blind technique. The operator is locating the anatomical landmarks and then performing the entire procedure blindly by percutaneous puncture. This is called the landmark technique. Second and new is the ultrasound-guided technique. The operator is locating the vein using ultrasonography and then performing the entire procedure under ultrasonographic visualization. The real time ultrasound-guided central venous catheterization became the standard of care in recent years mainly because of safety issues (is regarded as safer than landmark technique)

The catheterization of the axillary vein is not popular procedure in daily clinical practice. But it can be reasonable and safe alternative to others, typically performed central venous catheterizations like the internal jugular vein and the subclavian vein catheterizations.

The main intention of this study is to assess usefulness and safety of the real time ultrasound guided axillary vein catheterization in mechanically ventilated patients admitted to the intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

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
      • Opole, Poland, 45-418
        • Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne 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
  • history of multiple central venous catheterizations (three or more)
  • chest wall deformities
  • major blood coagulation disorders
  • history of thoracic surgery
  • 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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: axillary vein catheterization
central venous catheter placement into the axillary vein under ultrasound guidance
Procedure: ultrasound
catheterization of the axillary vein under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to define venipuncture, catheterization and entire procedure success rates
Time Frame: 24 hours
the venipuncture is defined as perforation of the axillary vein by the needle, the catheterization is defined as the placement of catheter in the final position, the entire procedure success rate is defined as the placement of catheter in the final position without early complications (assessed within 24 hours time frame)
24 hours
to assess the erly complication rate of ultrasound-guided axillary vein catheterization
Time Frame: 24 hours
pneumothorax, puncture of the axillary artery, hemothorax, heart perforation, catheter malposition, significant arrhythmias, air embolism
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the correlation between entire procedure success rate and the side of catheterization
Time Frame: 2 years
the left axillary vein or the right axillary vein
2 years
to assess the correlation between patients weight, height and depth, diameter of the axillary vein
Time Frame: 2 years
the depth and diameter of the axillary vein is measured by ultrasonography
2 years

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, Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 4, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 10, 2016

Last Update Submitted That Met QC Criteria

May 8, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Axillary-US-guided-1
  • Axillary-1 (Other Identifier: PS ZOZ Wojewodzkie Centrum Medyczne w Opolu)

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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