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NCT02975622 Clinical Trial

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
Secondary ID
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. completion date
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

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
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