Clinical Trials Directory

Trials / Terminated

TerminatedNCT00327886

Managing Cyanosis Following Bidirectional Glenn Operation

A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation

Status
Terminated
Phase
Study type
Observational
Enrollment
150 (planned)
Sponsor
Children's Healthcare of Atlanta · Academic / Other
Sex
All
Age
1 Year
Healthy volunteers
Not accepted

Summary

The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.

Detailed description

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

Conditions

Timeline

Start date
2006-02-01
Completion
2006-02-01
First posted
2006-05-19
Last updated
2007-06-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00327886. Inclusion in this directory is not an endorsement.