The EquiOx Real-World Study 2022-23
Study Description and Goals
ClinicalTrials.gov NCT05554510
This study is a real-world, prospective clinical trial of pulse oximeter performance in adult, critically-ill patients of different skin pigmentation classes at San Francisco General Hospital. The study is designed to overcome challenges in interpreting previous retrospective clinical studies on skin pigment and pulse oximeter performance, by quantifying five key parameters: 1. objective rather than self-reported skin pigmentation (using multiple color scales and colorimeters), 2. stability of conditions at time of blood gas (functional sO2) comparison and pulse oximeter reading (SpO2), 3. measurement of peripheral perfusion, 4. recording of type of oximeter, probe and site of probe placement, and 5. inclusion of a balanced population of diverse patients. The study will also collect raw oximeter signal data and multiple clinical variables that may impact oximeter performance. All de-identified oximeter performance data from the study will be shared via OpenOximetry (online data repository coming in early 2023). The study protocol will be shared at the top of this page for other initiatives interested in collecting and sharing data.
Enrollment for the study opened August 2022.
Funder: US Food and Drug Administration, CERSI