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

• Sponsor: Children's Healthcare of Atlanta (Other)
• Overall Status: Completed
• CT.gov ID: NCT00328146
• Collaborator: (none)
• Enrollment: 802
• Location: 1
• Duration (Months): 104
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Congenital Disorders	Other: 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

Study Design

• Study Type: Observational
• Actual Enrollment: 802 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Re-operative Surgery in Children: A Technique for Sternal Re-Entry
• Study Start Date: Feb 1, 2001
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Observation of Sternal Re-entry All subjects.	Other: Observation of sternal reentry; Observation of sternal reentry

Outcome Measures

Primary Outcome Measures

1. Present an effective techniqe for sternal re-entry in children. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Healthcare of Atlanta
• ClinicalTrials.gov Identifier: NCT00328146
• Other Study ID Numbers: 06-105
• First Posted: May 19, 2006
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

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

Study Results

No Results Posted as of Mar 1, 2017