Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD
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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 |
| Enrollment: | 1000 |
| Study Start Date: | November 2005 |
| Study Completion Date: | September 2007 |
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 |
retro chart review
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| United States, Georgia | |
| Children's Healthcare of Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| 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 |
Additional relevant MeSH terms:
|
Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 21, 2013