NCT00261989

Brief Summary

The aim of this study is to describe the presenting pulse oximetry reading in patients who have a known lesion which will cause them to have a low presenting oximetry reading. The study hypothesis is that there is a low presenting pulse oximetry in patients with congenital heart disease and that there will be no significant variation in the hourly variation in oximetry readings in these patients.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 6, 2011

Status Verified

September 1, 2007

First QC Date

December 2, 2005

Last Update Submit

July 5, 2011

Conditions

Congenital Disorders

Keywords

pulse oximetry readingspediatricscardiaccongenital heart disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retro chart review

You may qualify if:

  • congenital heart lesion
  • presenting to Sibley Heart Center
  • initial visit between Jan. 1, 2004 and Dec. 31, 2004

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital Abnormalities

Study Officials

  • William T Mahle, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 6, 2005

Study Start

November 1, 2005

Study Completion

September 1, 2007

Last Updated

July 6, 2011

Record last verified: 2007-09

Locations

US(1)