Comparison of the Oblique-axis and Long-axis Approaches for 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 oblique-axis and long-axis approaches 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 high bleeding risk

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. Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches 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 high bleeding risk

Official Title
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Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance in Cardiac Surgery Patients Susceptible to Bleeding: a Randomized Controlled Trial

Conditions
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Central Venous Catheterization

Intervention / Treatment
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* Procedure: Oblique-axis approach group
* Procedure: Long-axis approach group


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 Exclusion Criteria: the proximal and/or distal axillary vein was not clearly visualized or potentially unavailable for catheterization; did not receive or had not received oral antiplatelet drugs and/or anticoagulants for less than 3 days; already had presence of subclavian or axillary vein catheter; required an emergency axillary vein catheterization; had fracture of the ipsilateral clavicle or anterior proximal ribs; had subclavian and/or axillary vein thrombosis; had local infection of the puncture area.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oblique-axis approach group<br>The first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach. | Procedure: Oblique-axis approach group<br>* The first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach.<br>|
| Active Comparator: Long-axis approach group<br>The first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach. | Procedure: Long-axis approach group<br>* The first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis 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 3-5 minutes | 

Secondary Outcome Measures

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

 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