Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

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.

Conditions

Congenital Heart Disease in Children, Cardiomyopathies

Study Overview

Study Details

Study overview

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.

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

Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

Condition
Congenital Heart Disease in Children
Intervention / Treatment

-

Contacts and Locations

Palo Alto

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

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

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

Ages Eligible for Study

to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Study Record Dates

2024-10-01