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Completed

NCT Number: NCT03395691

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

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.

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Key information

Conditions

Central Venous Catheterization

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The distal approach

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

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.

Primary outcomes

  1. First puncture success rate

    Time frame: approximately 3 minutes

    Central venous catheter established upon first punction attempt

Secondary outcomes

  1. The approach success rate

    Time frame: within 1 hours

    the number of successful cannulation within the first two attempts

  2. Complication rate

    Time frame: Day 1

    major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, catheter misplacement

  3. time to successful cannulation

    Time frame: within 1 hours

    the time from skin puncture until completion of cannula insertion

  4. access time

    Time frame: within 1 hours

    defined as the time between penetration of skin and aspiration of venous blood into the syringe

  5. overall success rate

    Time frame: within 1 hours

    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)

  6. the number of attempts

    Time frame: within 1 hours

    the number of attempts until successful cannulation

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2018
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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