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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Central Venous Catheterization

Intervention / Treatment
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* Procedure: The distal approach
* Procedure: The proximal approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The distal approach<br>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. | Procedure: The distal approach<br>* 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<br>|
| Active Comparator: The proximal approach<br>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. | Procedure: The proximal approach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First puncture success rate | Central venous catheter established upon first punction attempt | approximately 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The approach success rate | the number of successful cannulation within the first two attempts | within 1 hours | 
| Complication rate | major bleeding, minor bleeding, arterial puncture, pneumothorax, nerve injuries, catheter misplacement | Day 1 | 
| time to successful cannulation | the time from skin puncture until completion of cannula insertion | within 1 hours | 
| access time | defined as the time between penetration of skin and aspiration of venous blood into the syringe | within 1 hours | 
| 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 | 
| the number of attempts | the number of attempts until successful cannulation | within 1 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillary vein, central venous catheterization, ultrasound, cardiac surgery, complication