Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance

Not Applicable

Recruiting

• Conditions: Central Venous Catheterization
• Interventions: Procedure: Long-axis approach group; Procedure: Oblique-axis approach group

• Registration Number: NCT04962945
• Lead Sponsor: Guowei Tu

Brief Summary

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

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

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study Start: 2021-07-06
• Study First Posted: 2021-07-15
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-axis approach group	Long-axis approach group	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.
Oblique-axis approach group	Oblique-axis approach group	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.

Primary Outcome Measures

Name	Time	Method
First puncture success rate	approximately 3-5 minutes	Central venous catheter established upon first punction attempt

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan hospital, Fudan university; 🇨🇳 Shanghai, China