Medium-term Venous Access in Congenital Heart Surgery

NCT ID: NCT00852488

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Congenital Heart Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Catheter

Cohort undergoing catheter placement using the new technique being studied

Group Type EXPERIMENTAL

Placement of transthoracic catheter

Intervention Type PROCEDURE

Placement of transthoracic catheter into the inferior vena cava

Interventions

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Placement of transthoracic catheter

Placement of transthoracic catheter into the inferior vena cava

Intervention Type PROCEDURE

Other Intervention Names

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Bard transthoracic catheter

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David Bichell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David P Bichell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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#080906

Identifier Type: -

Identifier Source: org_study_id

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