An Infraclavicular Landmark-based Approach to the Axillary Vein

Critical Illness Clinical Trial

Official title:

A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083458
• Other study ID #: Axillary vein - WCM
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: June 13, 2016
• Start date: February 2010
• Est. completion date: February 2014

Study information

• Verified date: June 2016
• Source: Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The central line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring.

The procedure is performed by percutaneous puncture of large vein of the neck and the thorax

• internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava.

There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique.

The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in patients admitted to the intensive care unit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients admitted to the intensive care unit with indications for central venous catheterization

Exclusion Criteria:

• chest wall deformities at the cannulations side

• major hemostasis disorders

• infections at the catheterization site

• age less than 18 years

• lack of patients 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:
• Catheterization of the axillary vein.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful catheterizations.		24 hours	Yes
Primary	Procedure success rate depending on physician experience.		24 hours	Yes
Secondary	Rate of early complications.		24 hours	Yes