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Medium-term Venous Access in Congenital Heart Surgery

This study has been completed.
Information provided by (Responsible Party):
David Bichell, Vanderbilt University Medical Center Identifier:
First received: February 4, 2009
Last updated: April 27, 2017
Last verified: February 2010
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.

Condition Intervention
Congenital Heart Surgery Procedure: Placement of transthoracic catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Medium-term Venous Access Alternative in Infants Undergoing Congenital Heart Surgery

Resource links provided by NLM:

Further study details as provided by David Bichell, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: March 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Catheter
Cohort undergoing catheter placement using the new technique being studied
Procedure: Placement of transthoracic catheter
Placement of transthoracic catheter into the inferior vena cava
Other Names:
  • Bard
  • transthoracic catheter


Ages Eligible for Study:   up to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00852488

United States, Tennessee
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Principal Investigator: David P Bichell, M.D. Vanderbilt University
  More Information

Responsible Party: David Bichell, Professor, Vanderbilt University Medical Center Identifier: NCT00852488     History of Changes
Other Study ID Numbers: #080906
Study First Received: February 4, 2009
Last Updated: April 27, 2017 processed this record on July 25, 2017