Medium-term Venous Access in Congenital Heart Surgery

Vanderbilt University Medical Center

Status: Completed

Conditions: Congenital Heart Surgery

Treatments: Procedure: Placement of transthoracic catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00852488

#080906

Details and patient eligibility

About

This study is designed to evaluate medium-term central venous catheter placement in infants undergoing complex cardiac surgery using a new technique. This technique involves placement of the catheter into the inferior vena cava through a subcutaneous tunnel and through a tunnel between pericardium and diaphragm.

Enrollment: 50 patients

Sex: All

Ages: 1 to 365 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants undergoing surgical correction or palliation of congenital heart disease via sternotomy
• Age 0-365 days
• Anticipated intensive care stay over 10 days
• Need for central venous access or prolonged venous access

Exclusion criteria

• Presence of access that is likely to last more than 10 days at time of operation
• Septic shock
• Known inferior vena cava thrombosis
• Operations not approached by sternotomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Catheter

Experimental group

Description:

Cohort undergoing catheter placement using the new technique being studied

Treatment:

Procedure: Placement of transthoracic catheter