RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-14
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06529575

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.

Ages Eligible for Study:4 Weeks to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Child is between 1 month and 18 years old
  2. * 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.
  1. * Child previously participated in the study
  2. * Child has differential cyanosis across extremities
  3. * Child is receiving an intravenous vasoconstrictor prior to procedure
  4. * Child has a ventricular assist device (VAD)

Contacts and Locations

Study Contact

Halley Ruppel, PhD
CONTACT
267-426-0220
hruppel@nursing.upenn.edu
Michelle Dunn
CONTACT
8324445631
medpenn@nursing.upenn.edu

Principal Investigator

Halley Ruppel, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Michael O'Byrne, MD, MSCE
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-14
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-08-14
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Pulse Oximetry

Additional Relevant MeSH Terms

  • Pediatric ALL
  • Cardiac Defect