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  1. Advancing Regulatory Science

Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children

CERSI Collaborator: Stanford University: Christopher S. Almond, MD, MPH; Chandra Ramamoorthy, MBBS, FRCA; Rebecca Kameny, MD; Greg Adamson, MD; Desirée R. Conrad, MD; Selena Gonzales, MPH

FDA Collaborators: Michelle Tarver, MD, PhD; Allison O’Neill, PhD; Gene Pennello, PhD; Rebecca Ward, MPH; Rebecca Torguson, MPH; Vasum Peiris, MD; Damia Jackson, GWCPM

Project Start Date: August 25, 2022

Regulatory Science Challenge

A pulse oximeter is a device that is usually placed on a fingertip to estimate the amount of oxygen in the blood. These devices were used more than usual during the COVID-19 pandemic. This study will address some concerns related to the accuracy of pulse oximeter readings among children with darker skin pigmentation (color). The project will assess if pulse oximeter errors are related to skin pigmentation or other factors such as a patient’s poor perfusion (flow of blood) or other health conditions.

While most of the studies reported in the scientific literature are on the adult population, a few have been conducted in children. Existing studies in children lack data on the relationship between pulse oximeter reading accuracy and skin pigmentation. The existing studies do not include information from skin pigmentation assessments, and simultaneous blood oxygen level measurements by pulse oximeter (SpO2) and arterial blood line (SaO2). The goal of this study is to evaluate pulse oximeter performance in hospitalized pediatric patients (21 years old and younger) of different skin pigmentation levels. Understanding how pulse oximeter devices perform in clinical practice is important to protecting public health.

Project Description and Goals

The study will assess the level of error in pulse oximeter readings for oxygen blood saturation levels (SpO2) across skin pigmentation groups. Additionally, researchers will assess the extent to which factors such as low perfusion and/or light transmittance may have an impact on the accuracy of pulse oximeter readings. The study is designed to capture skin pigmentation, simultaneous blood oxygen measurements by SpO2 and SaO2, measurement of patients’ peripheral perfusion (the flow of blood to the extremities of the body), type of pulse oximeter, probe and site of probe placement, among different patient populations. Skin pigmentation will be captured by colorimetry tools, and numerical scales for classification (Fitzpatrick and von Luschan scales). Data on other factors that may impact the performance of pulse oximeters such as demographics, body levels of carboxyhemoglobin (carbon monoxide and hemoglobin compound), presence of multiple simultaneous medical conditions, supplemental oxygen therapy, and core temperature will be captured from electronic health records.

The study is being conducted at the Heart Center at Stanford’s Lucile Packard Children’s Hospital. Children who are undergoing cardiac catheterization, cardiac surgery, or are hospitalized in the Cardiovascular ICU and have an arterial blood line qualify to be included in the study.


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