Trials / Completed
CompletedNCT00328146
Re-operative Surgery in Children:A Technique for Sternal Re-Entry
Re-operative Surgery in Children: A Technique for Sternal Re-Entry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 802 (actual)
- Sponsor
- Children's Healthcare of Atlanta · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 Children's Healthcare of Atlanta, Egleston Hospital. Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observation of sternal reentry | Observation of sternal reentry |
Timeline
- Start date
- 2001-02-01
- Primary completion
- 2009-10-01
- Completion
- 2009-10-01
- First posted
- 2006-05-19
- Last updated
- 2017-03-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00328146. Inclusion in this directory is not an endorsement.