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

NCT ID: NCT04962945

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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Central Venous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Oblique-axis approach group

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Long-axis approach group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guowei Tu

OTHER

Sponsor Role lead

Responsible Party

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Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhe Luo, Professor

Role: STUDY_DIRECTOR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-wei Tu, MD

Role: CONTACT

+86-021-64041990

Ying Su, MD

Role: CONTACT

+86-021-64041990

Facility Contacts

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Guo-wei F Tu, MD

Role: primary

+86-021-64041990

Ying Su, MD

Role: backup

+86-021-64041990

Other Identifiers

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B2021-018R

Identifier Type: -

Identifier Source: org_study_id

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