Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial

Not Applicable

• Conditions: Catheterization, Central Venous; Ultrasonography
• Interventions: Procedure: Central venous catheterization

• Registration Number: NCT02975622
• Lead Sponsor: Hospital Nossa Senhora da Conceicao

Brief Summary

Ultrasound (US)-guided central venous catheterization is now considered standard of care according to recent clinical evidence, at least considering jugular vein approach. Recent trials suggested that even US-guided subclavian approach could be more effective that landmark technique. However, studies comparing both sites employing US are still lacking.

We, therefore, designed a non-inferiority randomized controlled trial to compare these sites, both using US guidance, according to immediate complications following central venous catheterization.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

• critically ill patients; central venous access indicated.

Exclusion Criteria

• cardiac arrest; at least one side of each vein available for insertion; pacemaker insertion; pulmonary artery catheter insertion; non-corrected coagulopathy; thrombolytics in the past 24 hours.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subclavian	Central venous catheterization	Subclavian vein will be individualized and approached by longitudinal incidence, according to previous studies. Skin puncture will be made next to the transducer, lateral to the first rib, maintaining constant visualization of the needle tip.
Jugular	Central venous catheterization	Jugular vein will be identified by transverse or longitudinal approach, and skin puncture will be made by transverse or longitudinal incidence, according to operator's preferences. Using transverse approach, the needle will be maintained in a 45 degree angle with the skin, and the insertion site will be exactly the same as the measured distance between asking and jugular vein wall.

Primary Outcome Measures

Name	Time	Method
Immediate complications	24 hours

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil