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Completed

NCT Number: NCT01919528

Ultrasound-guided Catheterization of the Axillary Vein

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Opole, 45-418, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Procedure

catheterization of the axillary vein under ultrasound guidance

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2013
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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