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

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Disorders
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 802

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any child undergoing re-operative cardiac surgery through a midline sternotomy incision. This is a chart review.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Present an effective techniqe for sternal re-entry in children.

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Brian E Kogon, MD, Children's Healthcare of Atlanta

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: May 18, 2006
• First Submitted That Met QC Criteria: May 18, 2006
• First Posted (Estimate): May 19, 2006

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; cardiac; re-operative surgery
• Other Study ID Numbers: 06-105