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

NCT ID: NCT03395691

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-11
• Study Completion Date: 2019-09-17

Brief 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.

Detailed 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.

Conditions

Central Venous Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

The distal approach

Intervention Type: PROCEDURE

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.

Group Type: ACTIVE_COMPARATOR

The proximal approach

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guo-wei Tu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Countries

China

References

Buzancais 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.

Reference Type: BACKGROUND

PMID: 26787790 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28289815 (View on PubMed)

Su Y, Hou JY, Ma GG, Hao GW, Luo JC, Yu SJ, Liu K, Zheng JL, Xue Y, Luo Z, Tu GW. Comparison of the proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA) in cardiac surgery patients susceptible to bleeding: a randomized controlled trial. Ann Intensive Care. 2020 Jul 8;10(1):90. doi: 10.1186/s13613-020-00703-6.

Reference Type: DERIVED

PMID: 32643012 (View on PubMed)

Other Identifiers

PANDA

Identifier Type: -

Identifier Source: org_study_id