Clinical trial NCT04962945: Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Venous Catheterization
Keywords: axillary vein
central venous catheterization
ultrasound
cardiac surgery
complication
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: First puncture success rate
timeFrame: approximately 3-5 minutes
Secondary outcomes:
measure: approach success rate
timeFrame: within 1 hours
measure: strategy success rate
timeFrame: within 1 hours
measure: the number of attempts
timeFrame: within 1 hours
measure: access time
timeFrame: within 1 hours
measure: time to successful cannulation
timeFrame: within 1 hours
measure: Complications rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
affiliation: Fudan University
name: Zhe Luo, Professor
role: STUDY_DIRECTOR
References: