Overview

This trial has been completed.

Condition congenital disorders
Treatment observation of sternal reentry
Sponsor Children's Healthcare of Atlanta
Start date February 2001
End date October 2009
Trial size 802 participants
Trial identifier NCT00328146, 06-105

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model other
Time perspective retrospective
Arm
All subjects.
observation of sternal reentry
Observation of sternal reentry

Primary Outcomes

Measure
Present an effective techniqe for sternal re-entry in children.
time frame:

Eligibility Criteria

All participants up to 18 years old.

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

Additional Information

Official title Re-operative Surgery in Children: A Technique for Sternal Re-Entry
Principal investigator Brian E Kogon, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Children's Healthcare of Atlanta.