Managing Cyanosis Following Bidirectional Glenn Operation
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|ClinicalTrials.gov Identifier: NCT00327886|
Recruitment Status : Terminated
First Posted : May 19, 2006
Last Update Posted : June 13, 2007
|Condition or disease|
Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic.
Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005.
We will assign each chart a unique study number and collect data of:
date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications
|Study Type :||Observational|
|Enrollment :||150 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation|
|Study Start Date :||February 2006|
|Study Completion Date :||February 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327886
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Janet M Simsic, MD||Sibley Heart Center Cardiology, Children's Healthcare of Atlanta|