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Study Protocols - OpenOximetry
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class="list__single"> <button data-g-lang-label="Português" data-g-lang="pt" class="single__button notranslate " aria-label="Change language" >Português</button> </li> </ul> </div> </div> </div> <button id="hamburger" class="content__hamburger" aria-label="Show/hide mobile menu"> <div class="hamburger-box"> <div class="hamburger-inner"></div> </div> </button> </div> </div> </header> <main id="main_content" class="DefaultTemplate"> <section class="HeadingStandard"> <div class="row"> <div class="HeadingStandard__row"> <div class="image-wrapper image-wrapper--svg row__icon"> <div class="asset"> <picture class="lazy-load-item" data-alt="study-protocols-icon-evujgw" data-iesrc="https://openoximetry.org/wp-content/uploads/2023/02/study-protocols-icon-evujgw.svg" > <source srcset="https://openoximetry.org/wp-content/uploads/2023/02/study-protocols-icon-evujgw.svg" sizes="100vw"> </picture> </div> </div> <h1 class="row__title">Study Protocols</h1> </div> <p class="HeadingStandard__description">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. Please cite as "Open Oximetry Protocol for "*", 2023, OpenOximetry.org"</p> </div> </section> <div class="DefaultTemplate__box"> <div class="StickySubNav StickySubNav--theme-1" data-jsmodule="StickySubNav" data-id="67b89db6d886a"> <ul id="1336_67b89db6d886a_page_nav" class="StickySubNav__content"> <li class="content__item"> <a href="#lab-protocols-0" class="item__link " > <span class="link__content">Lab Protocols</span> </a> </li> <li class="content__item"> <a href="#clinical-trial-protocols-1" class="item__link " > <span class="link__content">Clinical Trial Protocols</span> </a> </li> <li class="content__item"> <a href="#openox-studies-2" class="item__link " > <span class="link__content">OpenOx Studies</span> </a> </li> </ul> </div> <section id="lab-protocols-0" tabindex="-1" class="ElasticContentBg ElasticContentBg__background--gray ElasticContentBg__contentSpaces--narrow "> <div class="ElasticContentBg__container"> <div class="row"> <div class="ElasticContentBg__box"> <div class="box__content"><h2><strong>Lab Protocols:</strong></h2> <ul> <li><a href="https://docs.google.com/document/d/1bpVzZg9M0StLoyB_iF07V8at0h8lQhDyYnNCoSMVZQU/edit?usp=sharing" target="_blank" rel="noopener">Laboratory-based, controlled hypoxemia pulse oximeter human study protocol</a> (Updated 04.2024) <ul> <li><a href="https://openoximetry.org/oximeters/" target="_blank" rel="noopener">List of devices independently being reviewed for testing</a></li> <li><a href="https://docs.google.com/presentation/d/1hTEodmr5iuRrJBRfJVcMjYcJQwh5vjES2hoYKfErCyU/edit?usp=sharing">Study recruitment materials </a></li> <li><a href="https://docs.google.com/presentation/d/1f5KnlymQbJzPkCiNWl6CDd33kGS59iMqRtHWIXHTNB0/edit?usp=sharing" target="_blank" rel="noopener">Hypoxia breathe down protocol</a> (Updated 11.2023)</li> </ul> </li> <li><a href="https://docs.google.com/document/d/17SGVjf1phxyhBB3TvetyuOFN_UC5z2humiEHI4dcEro/edit?usp=sharing" target="_blank" rel="noopener">Skin color quantification for pulse oximeter human study protocol</a> (Updated 01.2024)</li> <li><a href="https://docs.google.com/document/d/1yMcQNFIEkv_eZVBtgSIt25d8xEY3olVAa3bWjBzBdmQ/edit?usp=sharing" target="_blank" rel="noopener">Functional (in vitro) tester protocol for signal adequacy</a> (Updated 09.2023)</li> <li><a href="https://docs.google.com/document/d/1xY-Nf3aE7jSOfqqCmKfy9hJX5rpBRubOKFdP5V5o5Sc/edit?usp=sharing" target="_blank" rel="noopener">How to capture raw PPG signal</a> (Updated 01.2023)</li> </ul> </div> </div> </div> </div> </section> <section id="clinical-trial-protocols-1" tabindex="-1" class="ElasticContentBg ElasticContentBg__background--gray ElasticContentBg__contentSpaces--narrow "> <div class="ElasticContentBg__container"> <div class="row"> <div class="ElasticContentBg__box"> <div class="box__content"><h2><strong>Clinical Trial Protocols:</strong></h2> <ul> <li><a href="https://docs.google.com/document/d/17SGVjf1phxyhBB3TvetyuOFN_UC5z2humiEHI4dcEro/edit?usp=sharing" target="_blank" rel="noopener">Skin color quantification for pulse oximeter human study protocol</a> (Updated 01.2024)</li> <li><a href="https://docs.google.com/document/d/1XGXkZsaAWfPbcJRekAcaaHN7se-56o02a0lABqdoxwk/edit?usp=sharing" target="_blank" rel="noopener">Real world clinical study of pulse oximeter performance in critically-ill adults</a> and pediatric patients (Updated 01.2024) <ul> <li><a href="https://drive.google.com/file/d/1o0V2tplTcOq2IMBDcABQcvU1zNtg-BPh/view?usp=sharing">RedCap Data Dictionary</a> (Updated 09.2023)</li> <li><a href="https://docs.google.com/spreadsheets/d/1h_RAfjh-J-8hJ8bNd3gENFXJzpfYEomT9k5oJZ6nm14/edit?usp=sharing" target="_blank" rel="noopener">Full list of data variables with definitions</a> (Updated 09.2023)</li> <li><a href="https://docs.google.com/presentation/d/1qZ6QCk_ewJQJG4mF9-p0hTB-FFMmbMAe/edit?usp=sharing&ouid=109055808219034800953&rtpof=true&sd=true" target="_blank" rel="noopener">OpenOx EquiOx Study Bedside Rapid Data Collection Tool </a></li> <li>UCSF/FDA IRB Approved Consents <ul> <li>Modified Waiver of Consent (<a href="https://drive.google.com/file/d/1k9QFFom3HTxLgOc4jYQ2TM-ekB_Du8Du/view?usp=sharing">English</a> | <a href="https://drive.google.com/file/d/1jJ4tRVn_tVhAQ1w9-uj1JPSZ8o-QzmVD/view?usp=sharing" target="_blank" rel="noopener">Spanish</a> | <a href="https://drive.google.com/file/d/13rp6rFTqgHOWswJuYLrnNRvUd6FQPJMe/view?usp=sharing" target="_blank" rel="noopener">Cantonese</a>)</li> <li>Consent (<a href="https://drive.google.com/file/d/1CxxtH8sWCoMJ6Y_-QH5scZimtrv4Re-r/view?usp=sharing" target="_blank" rel="noopener">English</a> | <a href="https://drive.google.com/file/d/1mUftQVL9X9C60QC0vQbhAm34H0W8qIrp/view?usp=sharing" target="_blank" rel="noopener">Spanish</a> | <a href="https://drive.google.com/file/d/1O4dDXiF5OJQycsXWA0Px7N498LI5SYUP/view?usp=sharing">Cantonese</a>)</li> </ul> </li> </ul> </li> <li><a href="https://docs.google.com/document/d/1xY-Nf3aE7jSOfqqCmKfy9hJX5rpBRubOKFdP5V5o5Sc/edit?usp=sharing" target="_blank" rel="noopener">How to capture raw PPG signal</a> (Updated 01.2023)</li> </ul> </div> </div> </div> </div> </section> <section id="openox-studies-2" tabindex="-1" class="ElasticContentBg ElasticContentBg__background--blue ElasticContentBg__contentSpaces--narrow "> <div class="ElasticContentBg__container"> <div class="row"> <h2 class="ElasticContentBg__heading">Our Studies</h2> <div class="ElasticContentBg__box"> <div class="box__content"><h3><strong>The EquiOx Real-World Study 2022-23</strong></h3> <label><strong><u>Study Description and Goals</u></strong></label> <label><a href="https://clinicaltrials.gov/ct2/show/NCT05554510?term=pulse+oximetry+errors&draw=2&rank=1" target="_blank" rel="noopener">ClinicalTrials.gov NCT05554510</a></label> <p>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.</p> <p>Enrollment for the study opened <strong>August 2022.</strong></p> <p><strong>Funder</strong>: US Food and Drug Administration, CERSI</p> </div> </div> </div> </div> </section> <section class="ElasticContentBg ElasticContentBg__background--blue ElasticContentBg__contentSpaces--narrow "> <div class="ElasticContentBg__container"> <div class="row"> <div class="ElasticContentBg__box"> <div class="box__content"><h2><strong>The EquiOx-Lab Study</strong></h2> <label><strong><u>Study Description and Goals</u></strong></label> <p>We have tested hundreds of oximeters over the years in our lab and have published some of these data, including one study in <a href="https://pubmed.ncbi.nlm.nih.gov/27089002/" data-auth="NotApplicable" data-safelink="true" data-linkindex="0"><span style="font-style: inherit; font-weight: inherit;">2016</span></a>, 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.</p> <p>Enrollment for the study is <a href="https://hypoxialab.com/contact">open</a></p> <p><strong>Funder</strong>: Gordon and Betty Moore Foundation, Robert Wood Johnson Foundation, Patrick J. 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Independent device testing for the Open Oximetry Project follows <a href="https://docs.google.com/document/d/1bpVzZg9M0StLoyB_iF07V8at0h8lQhDyYnNCoSMVZQU/edit" target="_blank" rel="noopener">our protocol consistent with ISO and FDA</a>. Only devices labeled as ‘verified’ or ‘failed’ have been independently tested by the Open Oximetry Project.<br /> All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:</p> </div> <div class="content__table"> <div class="table__grid table__grid--col-0-heading" style="grid-template-columns: repeat( 4, minmax(160px, 1fr) );"> <div class="grid__cell grid__cell--header grid__cell--col-0">Score</div> <div class="grid__cell grid__cell--header grid__cell--col-1">Root mean square error (Arms) composite all skin colors & all perfusions tested 2022 FDA/ISO <span>(manufacturer* or independent testing)</span></div> <div class="grid__cell grid__cell--header grid__cell--col-2">Skin color</div> <div class="grid__cell grid__cell--header grid__cell--col-3">Perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-1" >1 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-1" >>4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-2" >2 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-2" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-2" >AND/OR Data suggesting Arms for dark skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-2" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-3" >3 (yellow)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-3" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-3" >AND/OR Data suggesting Arms for dark skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-3" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-4" >4 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-4" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-4" >AND No data for or against performance problems in darker skin colors</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-4" >AND No data for or against performance problems in low perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-5" >5 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-5" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> </div> <span class="table__caption">* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark Lab) get labeled as ‘verified’</span> </div> </div> </section> <script src="https://openoximetry.org/wp-content/themes/oximetry/build/DefaultTemplate.js?f0cff159"></script> </body> </html>