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

NCT04962945 | Unknown DMC

• 1 other identifier: B2021-018R
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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

Conditions

Central Venous Catheterization

Keywords

axillary vein; central venous catheterization; ultrasound; cardiac surgery; complication

Outcome Measures

Primary Outcomes (1)

• First puncture success rate

  Central venous catheter established upon first punction attempt

  approximately 3-5 minutes

Secondary Outcomes (6)

• approach success rate

  within 1 hours

• strategy success rate

  within 1 hours

• the number of attempts

  within 1 hours

• access time

  within 1 hours

• time to successful cannulation

  within 1 hours

Study Arms (2)

Oblique-axis approach group

ACTIVE COMPARATOR

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

Long-axis approach group

ACTIVE COMPARATOR

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

Interventions

Oblique-axis approach group PROCEDURE

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.

Oblique-axis approach group

Long-axis approach group PROCEDURE

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.

Long-axis approach group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
• Axillary vein catheterization is needed according to the clinical practice

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guowei Tu: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, 200030, China

RECRUITING

Study Officials

• Zhe Luo, Professor

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Guo-wei Tu, MD

CONTACT

+86-021-64041990; tu.guowei@zs-hospital.sh.cn

Ying Su, MD

CONTACT

+86-021-64041990; su.ying@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Secretary for Department of Critical Care Medcine

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 15, 2021
• Study Start: July 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CN (1)