Medium-term Venous Access in Congenital Heart Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Surgery
• Interventions: Procedure: Placement of transthoracic catheter

• Registration Number: NCT00852488
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Study Start: 2009-03
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-02
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Catheter	Placement of transthoracic catheter	Cohort undergoing catheter placement using the new technique being studied

Primary Outcome Measures

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

Trial Locations

Locations (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States