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

Central Venous Catheterization Clinical Trial

Official title:

Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance in Cardiac Surgical Patients With Risk of Bleeding: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395691
• Other study ID #: PANDA
• Status: Completed
• Phase: N/A
• Start date: February 11, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: September 2019
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: September 17, 2019
• Est. primary completion date: September 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

Procedure:
• The distal approach
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
• The proximal approach
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.

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Buzançais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458. — View Citation

Vezzani A, Manca T, Brusasco C, Santori G, Cantadori L, Ramelli A, Gonzi G, Nicolini F, Gherli T, Corradi F. A randomized clinical trial of ultrasound-guided infra-clavicular cannulation of the subclavian vein in cardiac surgical patients: short-axis versus long-axis approach. Intensive Care Med. 2017 Nov;43(11):1594-1601. doi: 10.1007/s00134-017-4756-6. Epub 2017 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First puncture success rate	Central venous catheter established upon first punction attempt	approximately 3 minutes
Secondary	The approach success rate	the number of successful cannulation within the first two attempts	within 1 hours
Secondary	Complication rate	major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, catheter misplacement	Day 1
Secondary	time to successful cannulation	the time from skin puncture until completion of cannula insertion	within 1 hours
Secondary	access time	defined as the time between penetration of skin and aspiration of venous blood into the syringe	within 1 hours
Secondary	overall success rate	defined as the number of successful cannulation in targeted axillary vein within four attempts (the first two attempts using the randomized approach, third and fourth attempts using the non-randomized approach)	within 1 hours
Secondary	the number of attempts	the number of attempts until successful cannulation	within 1 hours