Medium-term Venous Access in Congenital Heart Surgery

Vanderbilt University Medical Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Congenital Heart Surgery

Interventions

Placement of transthoracic catheterPROCEDURE

Placement of transthoracic catheter into the inferior vena cava

Eligibility

Sex: ALLMin age: 1 DayMax age: 365 Days

Medical Language ↔ Plain English

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

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.

Time frame: Until catheter no longer needed; it is not anticipated that these remain longer than 2 weeks. Prior to discharge all will have been removed and final assessment of primary outcome will be obtained

Data from ClinicalTrials.gov

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