Ultrasound-guided Catheterization of the Axillary Vein

NCT01919528 | Completed

• 2 other identifiers: Axillary-US-guided-1Axillary-1
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

ultrasonography; catheterization; central line; mechanical ventilation; intensive care; axillary vein

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• to assess the correlation between entire procedure success rate and the side of catheterization

  2 years

• to assess the correlation between patients weight, height and depth, diameter of the axillary vein

  2 years

Study Arms (1)

axillary vein catheterization

EXPERIMENTAL

central venous catheter placement into the axillary vein under ultrasound guidance

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

catheterization of the axillary vein under ultrasound guidance

axillary vein catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniwersytecki Szpital Kliniczny w Opolu: lead

Study Sites (1)

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

Opole, 45-418, Poland

Location

Related Publications (2)

• 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.

  PMID: 25697988 RESULT

• 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.

  PMID: 26993368 RESULT

MeSH Terms

Conditions

Critical Illness

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Tomasz Czarnik, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior anesthesiologist

Study Record Dates

• First Submitted: August 4, 2013
• First Posted: August 9, 2013
• Study Start: December 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

PL (1)