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Re-operative Surgery in Children:A Technique for Sternal Re-Entry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00328146
First Posted: May 19, 2006
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
  Purpose
Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Condition Intervention
Congenital Disorders Other: Observation of sternal reentry

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Re-operative Surgery in Children: A Technique for Sternal Re-Entry

Further study details as provided by Children's Healthcare of Atlanta:

Primary Outcome Measures:
  • Present an effective techniqe for sternal re-entry in children.

Enrollment: 802
Study Start Date: February 2001
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation of Sternal Re-entry
All subjects.
Other: Observation of sternal reentry
Observation of sternal reentry

Detailed Description:

Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients.

Primary Aim: Present an effective technique for sternal re-entry in children

Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital.

Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any child undergoing re-operative cardiac surgery through a midline sternotomy incision. This is a chart review.
Criteria

Inclusion Criteria:

  • Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Exclusion Criteria:

  • Those who do not fall under the above inclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328146


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian E Kogon, MD Children's Healthcare of Atlanta
  More Information

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00328146     History of Changes
Other Study ID Numbers: 06-105
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: March 1, 2017
Last Verified: February 2017

Keywords provided by Children's Healthcare of Atlanta:
pediatric
cardiac
re-operative surgery