Ultrasonography Clinical Trial
— USCATHOfficial title:
Immediate Complications According to Ultrasound-guided Central Venous Catheters Insertion Site: a Non-inferiority Randomized Clinical Trial Comparing Jugular and Subclavian Approaches
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 |
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 |
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital Nossa Senhora da Conceicao | Hospital de Clinicas de Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate complications | 24 hours | Yes |
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