Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

Description

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.

Conditions

Pediatric ALL, Cardiac Defect

Study Overview

Study Details

Study overview

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.

Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

Condition
Pediatric ALL
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center, New York, New York, United States, 10032

Philadelphia

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Houston

Texas Children's Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Child is between 1 month and 18 years old
  • * Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.
  • * Child previously participated in the study
  • * Child has differential cyanosis across extremities
  • * Child is receiving an intravenous vasoconstrictor prior to procedure
  • * Child has a ventricular assist device (VAD)

Ages Eligible for Study

4 Weeks to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Halley Ruppel, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Michael O'Byrne, MD, MSCE, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2028-12