RECRUITING

Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

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

In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Official Title

Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation

Quick Facts

Study Start:2022-08-31
Study Completion:2024-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05617547

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:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≤21 years of age
  2. 2. Requires arterial vascular access as part of routine clinical care
  3. 3. Patient or legally authorized representative (LAR) willing to provide written informed consent
  1. 1. Anemia defined as a Hgb \<8 g/dL
  2. 2. Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurate
  3. 3. Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisable
  4. 4. Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO)
  5. 5. Lack of informed consent

Contacts and Locations

Study Contact

Christopher S Almond, MD, MPH
CONTACT
650-7237913
calmond@stanford.edu
Selena Gonzales, MPH
CONTACT
650-723-7913
selena.gonzales@stanford.edu

Study Locations (Sites)

Lucile Packard Children's Hospital
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

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 Date2022-08-31
Study Completion Date2024-10-01

Study Record Updates

Study Start Date2022-08-31
Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Congenital Heart Disease in Children
  • Cardiomyopathies