Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance

NCT03395691 | Completed DMC

• 1 other identifier: PANDA
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal approach 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 risk of bleeding.

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 minutes

Secondary Outcomes (6)

• The approach success rate

  within 1 hours

• Complication rate

  Day 1

• time to successful cannulation

  within 1 hours

• access time

  within 1 hours

• overall success rate

  within 1 hours

Study Arms (2)

The distal approach

ACTIVE COMPARATOR

The first two attempts via the distal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the proximal approach.

Procedure: The distal approach

The proximal approach

ACTIVE COMPARATOR

The first two attempts via the proximal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the distal approach.

Procedure: The proximal approach

Interventions

The distal approach PROCEDURE

The first two attempts via the distal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the proximal approach

The distal approach

The proximal approach PROCEDURE

The first two attempts via the proximal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the distal approach.

The proximal approach

Eligibility Criteria

• Age: 18 Years - 80 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
• receiving oral antiplatelet or anticoagulants at least three days

You may not qualify if:

• fracture of the ipsilateral clavicle or anterior proximal ribs
• subclavian and/or axillary vein thrombosis
• local infection of the puncture area
• subclavian and/or axillary veins which are not clearly visualized using ultrasound
• already presence of subclavian or axillary vein catheter
• requiring an emergency axillary vein catheterization

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

Related Publications (3)

• Buzancais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458.

  PMID: 26787790 BACKGROUND

• Vezzani A, Manca T, Brusasco C, Santori G, Cantadori L, Ramelli A, Gonzi G, Nicolini F, Gherli T, Corradi F. A randomized clinical trial of ultrasound-guided infra-clavicular cannulation of the subclavian vein in cardiac surgical patients: short-axis versus long-axis approach. Intensive Care Med. 2017 Nov;43(11):1594-1601. doi: 10.1007/s00134-017-4756-6. Epub 2017 Mar 13.

  PMID: 28289815 BACKGROUND

• Su Y, Hou JY, Ma GG, Hao GW, Luo JC, Yu SJ, Liu K, Zheng JL, Xue Y, Luo Z, Tu GW. Comparison of the proximal and distal approaches for axillary vein catheterization under ultrasound guidance (PANDA) in cardiac surgery patients susceptible to bleeding: a randomized controlled trial. Ann Intensive Care. 2020 Jul 8;10(1):90. doi: 10.1186/s13613-020-00703-6.

  PMID: 32643012 DERIVED

Study Officials

• Guo-wei Tu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were randomized to the Proximal Approach (PA) or Distal Approach (DA) group in a 1:1 ratio using a computerized system. The allocation process was intensively managed by an allocation group using sequentially numbered containers and the allocation result was concealed until it was implemented. When a patient was eligible, the investigator informed allocation group to get intervention group allocated to the patient: PA or DA group. Because of feasibility issues, operators were not blinded to the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 10, 2018
• Study Start: February 11, 2018
• Primary Completion: September 14, 2019
• Study Completion: September 17, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)