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

Ultrasonography Clinical Trial

— USCATH  

Official title:

Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial Comparing Jugular and Subclavian Approaches

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02975622
• Other study ID #: HCPA001
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: November 23, 2016
• Start date: August 2016

Study information

• Verified date: November 2016
• Source: Hospital Nossa Senhora da Conceicao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Catheterization, Central Venous
• Ultrasonography

Intervention

Procedure:
• Central venous catheterization
Ultrasound guided central venous catheterization

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao	Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate complications		24 hours	Yes