Ultrasound-guided Catheterization of the Axillary Vein

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919528
• Other study ID #: Axillary-US-guided-1
• Secondary ID: Axillary-1
• Status: Completed
• Phase: N/A
• First received: August 4, 2013
• Last updated: June 5, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• ultrasound
catheterization of the axillary vein under ultrasound guidance

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu	Opole

Sponsors (1)

Lead Sponsor	Collaborator
Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to define venipuncture, catheterization and entire procedure success rates	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	Yes
Primary	to assess the erly complication rate of ultrasound-guided axillary vein catheterization	pneumothorax, puncture of the axillary artery, hemothorax, heart perforation, catheter malposition, significant arrhythmias, air embolism	24 hours	Yes
Secondary	to assess the correlation between entire procedure success rate and the side of catheterization	the left axillary vein or the right axillary vein	2 years	No
Secondary	to assess the correlation between patients weight, height and depth, diameter of the axillary vein	the depth and diameter of the axillary vein is measured by ultrasonography	2 years	No