Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD

This study has been terminated.
(data insignificant, study terminated)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00261989
First received: December 2, 2005
Last updated: July 5, 2011
Last verified: September 2007
  Purpose

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.


Condition
Congenital Disorders

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Retrospective Analysis of Presenting Pulse Oximetry Readings and Hourly Variation in Oximetry Readings in Patients With Known Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 1000
Study Start Date: November 2005
Study Completion Date: September 2007
Detailed Description:

Congenital heart disease is a relatively common disease seen in 8/1,000 live births. Many of these diseases are associated with hypoxemia. Hypoxemia results from the mixing of pulmonary and systemic blood or from the mixing of parallel circulations as seen in transposition of the great vessels. Pulse oximetry can be used to measure hypoxemia. Pulse oximetry estimates oxygen saturation by measuring absorption of light in human tissue beds. The amount of light absorption varies depending on the amount of deoxygenated blood in the tissue measured. Measuring the changes in light absorption allows for an estimation of arterial oxygen saturation and therefore the amount of hypoxemia. Most manufacturers claim a confidence interval of 4% for their oximeters. There have been a few studies recently describing the presenting pulse oximetry of known congenital heart disease. However, these were small studies with a small sample size of patients. Moreover, there is no literature describing the hourly variation in pulse oximetry among know congenital heart disease patients.

We hypothesize 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.

This is a retrospective chart review examining the presenting pulse oximetry of patients with known cyanotic heart lesions. The treatment group will be untreated patients with known lesions. All charts of children presenting to Sibley Heart Center with known cyanotic heart lesions from January 1, 2004 to December 31, 2004 will be reviewed.

The aim of the study is to describe the presenting pulse oximetry reading in patients who have a known lesion which will cause them to have a low oximetry reading. The following information will be collected from the charts:

  • Presenting pulse oximetry
  • Heart lesion

The second aim will be to characterize the hourly variation in pulse oximetry from these patients. The following information will be collected:

  • Hourly pulse oximetry readings
  • Heart lesion
  • Clinical course
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

retro chart review

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • those who do not meet inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261989

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: William T Mahle, MD Children's Healthcare of Atlanta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00261989     History of Changes
Other Study ID Numbers: 05-198
Study First Received: December 2, 2005
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
pulse oximetry readings
pediatrics
cardiac
congenital heart disease

ClinicalTrials.gov processed this record on October 21, 2014