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

Hospital Nossa Senhora da Conceicao

Status: Unknown

Conditions: Ultrasonography; Catheterization, Central Venous

Treatments: Procedure: Central venous catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT02975622

HCPA001

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Subclavian

Active Comparator group

Description:

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.

Treatment:

Procedure: Central venous catheterization

Jugular

Active Comparator group

Description:

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.

Treatment:

Procedure: Central venous catheterization