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

NCT ID: NCT02975622

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Brief Summary

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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

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Conditions

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Catheterization, Central Venous Ultrasonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Central venous catheterization

Intervention Type PROCEDURE

Ultrasound guided central venous catheterization

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.

Group Type ACTIVE_COMPARATOR

Central venous catheterization

Intervention Type PROCEDURE

Ultrasound guided central venous catheterization

Interventions

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Central venous catheterization

Ultrasound guided central venous catheterization

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role collaborator

Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role lead

Responsible Party

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Jose Augusto Santos Pellegrini

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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José Augusto Santos Pellegrini, MD

Role: primary

Rafael Barberena Moraes, PhD

Role: backup

Other Identifiers

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HCPA001

Identifier Type: -

Identifier Source: org_study_id