Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529575
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACH
Brief Summary:
This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings Many factors can affect how well pulse oximeters work for example movement and even fingernail polish Some studies in adults show that skin color may also affect the pulse oximeter reading In this study we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the gold standard blood sample measurement
Detailed Description:
This multisite prospective observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization The primary aim of the study is to quantify pulse oximeter accuracy in children with varying skin colors Children undergoing cardiac catheterization are a unique population in which to study pulse oximeter accuracy because they have a wide range of baseline arterial oxygen saturations secondary to their cardiac conditions allowing for evaluation of pulse oximeter accuracy across a range of arterial oxygen saturations Children undergoing cardiac catheterization are continuously monitored with pulse oximeters and also have direct measurement of arterial blood oxygen via co-oximeter as part of routine care The results of this study will contribute much needed knowledge about pulse oximeter accuracy in children to better understand potential clinical implications
Dimensions of skin colors melanin index redness etc will be objectively measured using spectrophotometry During and after the catheterization procedure clinical data already collected during the course of clinical care will be recorded by the study team including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure The primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen
Dimensions of skin colors melanin index redness etc will be objectively measured using spectrophotometry During and after the catheterization procedure clinical data already collected during the course of clinical care will be recorded by the study team including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure The primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen
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