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Managing Cyanosis Following Bidirectional Glenn Operation

Terminated
Conditions
Congenital Disorders
Registration Number
NCT00327886
Lead Sponsor
Children's Healthcare of Atlanta
Brief 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

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Infants
  • Bidirectional Glenn operation between 1/1/03-12/31/05
  • Significant Cyanosis
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Exclusion Criteria
  • Those who do not meet inclusion criteria.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Children's Healthcare of Atlanta

🇺🇸

Atlanta, Georgia, United States

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