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

November 23, 2016 updated by: Jose Augusto Santos Pellegrini, Hospital Nossa Senhora da Conceicao

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subclavian
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.
Procedure: Central venous catheterization
Ultrasound guided central venous catheterization
Active Comparator: Jugular
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.
Procedure: Central venous catheterization
Ultrasound guided central venous catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immediate complications
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Nossa Senhora da Conceicao

Collaborators

Hospital de Clinicas de Porto Alegre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HCPA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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