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.
Lab Protocols:
- Laboratory-based, controlled hypoxemia pulse oximeter human study protocol (Updated 11.2022)
- Skin color quantification for pulse oximeter human study protocol (Updated 1.2023)
- Lab based in vitro studies (coming 2023)
- How to capture raw PPG signal (Updated 12.2022)
Clinical Trial Protocols:
- Skin color quantification for pulse oximeter human study protocol (Updated 1.2023)
- Real world clinical study of pulse oximeter performance in critically-ill adults and pediatric patients (Updated 10.2022)
- RedCap Data Dictionary (Updated 10.2022)
- Full list of data variables with definitions (Updated 10.2022)
- OpenOx EquiOx Study Bedside Rapid Data Collection Tool
- UCSF/FDA IRB Approved Consents
- How to capture raw PPG signal (Updated 12.2022)
Our Studies
The EquiOx Real-World Study 2022-23
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
The EquiOx-Lab Study
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, Robert Wood Johnson Foundation, Patrick J. McGovern Foundation