Study Protocols

We will be sharing research study protocols to maximize accuracy, equity and comparability of data collected by oximeter performance studies worldwide. These protocols will be iteratively developed by OpenOximetry Project collaborating research teams and based on the latest evidence. Protocols will include:

The EquiOx Real-World Study 2022-23

Study Description and Goals

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 on protocols.io very soon for other sites interested in collecting and sharing data.

Enrollment for the study opened August 2022.

Funder: US Food and Drug Administration, CERSI

The EquiOx-Lab Study

Study Description and Goals

We have tested hundreds of oximeters over the years in our lab and have published some of these data, including one study in 2016, where we published accuracy results on 6 low-cost oximeters. We have ramped up our testing due to renewed interest in the utility and performance oximeters, especially handheld and fingertip devices due to the COVID-19 Pandemic, as well as inquiries from Ministries of Health, aid agencies, regulator agencies, and individual donors and consumers. We are testing some of the most commonly encountered fingertip, handheld, and multi-modal oximeter devices on the market. Our focus is to improve health equity and increase diversity in populations in which pulse oximeters are tested. Like the EquiOx study, the EquiOx-L (lab-based) study is designed to overcome challenges in interpreting previous studies on skin pigment and pulse oximeter performance, by capturing expanded datasets not traditionally gathered in prior studies on pulse oximeters. This includes the data parameters mentioned above as well raw oximeter signal data. Similar to the EquiOx Study, we intend to share all de-identified data via a new open access data repository that is being built by the Open Oximetry Project.

Enrollment for the study is open

Funder: Gordon and Betty Moore Foundation

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