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

Central Venous Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962945
• Other study ID #: B2021-018R
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, MD
• Phone: +86-021-64041990
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guowei Tu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First puncture success rate	Central venous catheter established upon first punction attempt	approximately 3-5 minutes
Secondary	approach success rate	the number of successful cannulation within the first two attempts	within 1 hours
Secondary	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
Secondary	the number of attempts	the number of attempts until successful cannulation	within 1 hours
Secondary	access time	defined as the time between penetration of skin and aspiration of venous blood into the syringe	within 1 hours
Secondary	time to successful cannulation	the time from skin puncture until completion of cannula insertion	within 1 hours
Secondary	Complications rate	Complications included arterial puncture, pneumothorax, haemothorax, nerve injuries, hematoma, catheter misplacement	1 day