A Technique for Sternal Re-Entry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00328146
First received: May 18, 2006
Last updated: NA
Last verified: April 2006
History: No changes posted
  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
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Re-Operative Surgery in Children: A Technique for Sternal Re-Entry

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

Estimated Enrollment: 450
Study Start Date: February 2001
Estimated Study Completion Date: February 2006
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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00328146     History of Changes
Other Study ID Numbers: 06-105
Study First Received: May 18, 2006
Last Updated: May 18, 2006
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014