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

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

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 Overview

• Status: Recruiting
• Conditions: Central Venous Catheterization
• Intervention / Treatment: Procedure: Oblique-axis approach group; Procedure: Long-axis approach group

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 Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guo-wei Tu, MD; Phone Number: +86-021-64041990; Email: tu.guowei@zs-hospital.sh.cn
• Study Contact Backup: Name: Ying Su, MD; Phone Number: +86-021-64041990; Email: su.ying@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200030
    • Recruiting
    • Zhongshan Hospital, Fudan University
    • Contact: Ying Su, MD; Phone Number: +86-021-64041990; Email: su.ying@zs-hospital.sh.cn
    • Contact: Guo-wei F Tu, MD; Phone Number: +86-021-64041990; Email: tu.guowei@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

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
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
the number of attempts	the number of attempts until successful cannulation	within 1 hours
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
Complications rate	Complications included arterial puncture, pneumothorax, haemothorax, nerve injuries, hematoma, catheter misplacement	1 day

Collaborators and Investigators

• Sponsor: Guowei Tu
• Investigators: Study Director: Zhe Luo, Professor, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; ultrasound; complication; axillary vein; central venous catheterization
• Other Study ID Numbers: B2021-018R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No