Congenital Heart Surgery
Conditions
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.
Interventions
PROCEDUREPlacement of transthoracic catheter
Placement of transthoracic catheter into the inferior vena cava
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 365 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed