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NCT00327886 Clinical Trial

Managing Cyanosis Following Bidirectional Glenn Operation

Congenital Disorders Clinical Trial

Official title:
A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00327886
Other study ID # 06-029
Secondary ID
Status Terminated
Phase N/A
First received May 18, 2006
Last updated June 12, 2007
Start date February 2006
Est. completion date February 2006

Study information
Verified date June 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 150
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

- Infants

- Bidirectional Glenn operation between 1/1/03-12/31/05

- Significant Cyanosis

Exclusion Criteria:

- Those who do not meet inclusion criteria.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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