Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance

Fudan University

Status: Completed

Conditions: Central Venous Catheterization

Treatments: Procedure: The proximal approach; Procedure: The distal approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03395691

PANDA

Details and patient eligibility

About

Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal approach of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with risk of bleeding.

Full description

For patients after cardiac surgery, antiplatelet drugs or anticoagulants are usually used for preventing thrombosis. Use of those drugs is associated with increased risk of bleeding. Any invasive procedures may put those patients at additional risk of bleeding. Ultrasound (US) has become widely accepted to guide safe and accurate central venous catheterization.The axillary vein in the infraclavicular area is an alternative choice for subclavian vein. Ultrasound images of the infraclavicular axillary vein differ according to its position. Proximal infraclavicular axillary vein is a direct continuation of the subclavian vein. The associated anatomy is simple and the vein is straight and thick in longitudinal axis view, which are in favor of successful puncture. Meanwhile, distal axillary vein also has anatomical advantages for safe and successful cannulations. Distal axillary vein lies further away from the artery and chest wall, and the overlap between distal axillary vein and artery gets greater on moving laterally. It is still unknow that one of the puncture approaches is superior to the other. Until now, there are no studies comparing two puncture approaches in high bleeding risk patients. The aim of the study is to compare the success rate of first puncture and safety of US-guided proximal and distal axillary venous catheterization in cardiac surgery patients with risk of bleeding.

Enrollment: 198 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
• Axillary vein catheterization is needed according to the clinical practice
• receiving oral antiplatelet or anticoagulants at least three days

Exclusion criteria

• fracture of the ipsilateral clavicle or anterior proximal ribs
• subclavian and/or axillary vein thrombosis
• local infection of the puncture area
• subclavian and/or axillary veins which are not clearly visualized using ultrasound
• already presence of subclavian or axillary vein catheter
• requiring an emergency axillary vein catheterization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

The distal approach

Active Comparator group

Description:

The first two attempts via the distal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the proximal approach.

Treatment:

Procedure: The distal approach

The proximal approach

Active Comparator group

Description:

The first two attempts via the proximal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the distal approach.

Treatment:

Procedure: The proximal approach