Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575270
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Skin PigmentPulse Oximeter in Congenital Heart Disease CHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease A Prospective Observational Study
Status:
NOT_YET_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:
None
Brief Summary:
Recent retrospective studies have demonstrated differences between pulse oximeter values SpO2 and measured arterial oxygen saturation SaO2 in patients identifying as Black or Hispanic These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population
Detailed Description:
This is a prospective observational study aiming to evaluate the relationship between pulse oximeter accuracy to the measured level of skin pigmentation in pediatric patients with congenital heart disease CHD These patients live with varying levels of hypoxemia making them an ideal study population to investigate this critical patient safety issue The study population will be pediatric patients age 18 years old with a diagnosis of congenital heart disease presenting for cardiac surgery at the Mount Sinai Hospital These patients will undergo surgery as per protocol as if they were not in a research study but will have their skin pigment measured using a non-invasive device color spectrophotometer prior to surgery As part of the normal surgery protocols arterial blood gas samples will be completed The measured oxygen levels SaO2 on arterial blood gas will be compared to the pulse oximeter value using simultaneous measurements to ensure the measures are concurrent After cardiopulmonary bypass is initiated for the surgery the subjects involvement in the study will be completed
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