Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein

Central Venous Access Clinical Trial

— JI vs SC  

Official title:

Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162757
• Other study ID #: Local/2016/CR-02
• Status: Completed
• Phase: N/A
• Start date: January 26, 2017
• Est. completion date: November 23, 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 23, 2018
• Est. primary completion date: July 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights

• The patient have given their free and informed consent and signed the consent form

• The patient must be insured or a beneficiary of a health insurance plan

• The patient is over 18 years old

• The patient needs a venous catheter in the superior vena cava

Exclusion Criteria:

• The patient is already participating in another interventional study that could influence the results of this study

• The patient has participated in another interventional study within the previous 3 months that could influence the results of this study

• The patient is in a period of exclusion determined by a previous study

• The patient is under judicial protection or is an adult under guardianship

• The patient refuses to sign the consent form

• Non-echogenic patient

• Moribund patient

• The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic

• Patient has severe coagulation problems: PT<40%, platelets<50 000 and curable anticoagulation with antiXa > 0.5 or INR>3.

• Patient has a congenital or acquired deformation at the entry site

Related Conditions & MeSH terms

• Central Venous Access

Intervention

Procedure:
• Central venous catheterization
Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful placement catheter from a maximum of two attempts	Binary yes/no	During procedure
Secondary	Pneumothorax	binary yes/no	1 day
Secondary	arterial puncture	binary yes/no	within 1 hour
Secondary	failure	binary yes/no	within 1 hour
Secondary	arrhythmia	binary yes/no	within 1 hour
Secondary	abberant placement of catheter	binary yes/no	1 day
Secondary	catheter infection	binary yes/no	at removal of catheter; on average 6.5 days
Secondary	catheter colonization	binary yes/no	at removal of catheter; on average 6.5 days
Secondary	mediastinal hematoma	binary yes/no	1 day
Secondary	thrombosis	binary yes/no	until removal of catheter; on average 6.5 days
Secondary	success at first attempt	yes/no	within 1 hour
Secondary	time between puncture until insertion of guide	measure in seconds	within 1 hour
Secondary	clinical variables associated with failure of the techniques		within 24 hours
Secondary	number of dressings	per day	over length of hospitalization; maximum 40 days
Secondary	nurse-rated satisfaction at each dressing replacement	score 0-10	over length of hospitalization; maximum 40 days
Secondary	haemothorax	binary yes/no	1 day