Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261989
Status:
TERMINATED
Last Update Posted:
2011-07-06
First Post:
2005-12-02
Brief Title:
Pulse Oximetry Readings and Hourly Variation in Oximetry Readings With CHD
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
The Retrospective Analysis of Presenting Pulse Oximetry Readings and Hourly Variation in Oximetry Readings in Patients With Known Congenital Heart Disease
Status:
TERMINATED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
data insignificant study terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Congenital heart disease is a relatively common disease seen in 81000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None