A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Surgery
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Days of complication-free use. Morbidity (infection, malposition, bleeding, thrombosis, need for removal for catheter-related complication). Need for additional catheter placement or reintervention.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
David Bichell
Professor
Vanderbilt University Medical Center
Eligibility Criteria
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
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