Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328146
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2006-05-18
Brief Title:
Re-operative Surgery in ChildrenA Technique for Sternal Re-Entry
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Re-operative Surgery in Children A Technique for Sternal Re-Entry
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Childrens Healthcare of Atlanta Egleston Hospital
Inclusion Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision
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 Childrens Healthcare of Atlanta Egleston Hospital
Inclusion Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None