Clinical trial NCT01919528: Ultrasound-guided Catheterization of the Axillary Vein
Official title: Real-time Ultrasound-guided Catheterization of the Axillary Vein in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: ultrasonography
catheterization
central line
mechanical ventilation
intensive care
axillary vein
Lead sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: to define venipuncture, catheterization and entire procedure success rates
timeFrame: 24 hours
measure: to assess the erly complication rate of ultrasound-guided axillary vein catheterization
timeFrame: 24 hours
Secondary outcomes:
measure: to assess the correlation between entire procedure success rate and the side of catheterization
timeFrame: 2 years
measure: to assess the correlation between patients weight, height and depth, diameter of the axillary vein
timeFrame: 2 years
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
name: Tomasz Czarnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czarnik T, Gawda R, Nowotarski J. Real-time, ultrasound-guided infraclavicular axillary vein cannulation for renal replacement therapy in the critical care unit-A prospective intervention study. J Crit Care. 2015 Jun;30(3):624-8. doi: 10.1016/j.jcrc.2015.01.002. Epub 2015 Jan 8.
citation: Czarnik T, Gawda R, Nowotarski J. Real-time ultrasound-guided infraclavicular axillary vein cannulation: A prospective study in mechanically ventilated critically ill patients. J Crit Care. 2016 Jun;33:32-7. doi: 10.1016/j.jcrc.2016.02.021. Epub 2016 Mar 2.