Working with Us

The UCSF Hypoxia Labs works with a range of collaborators including research teams from UCSF and international universities, device manufacturers, product designers, leading global health authorities, regulatory bodies and more. Together, we conduct the highest quality research to help improve device safety and equity.

If you are interested in conducting a study with the UCSF Hypoxia Lab, please reach out to our clinical research coordination team. Please include the following emails in your inquiry: ella.behnke@ucsf.edu, hypoxialab@ucsf.edu.

Information about setting up a study, our study protocols, and data collection processes can be found here.

Our Services

The Hypoxia Lab has numerous study protocols to test a variety of physiologic conditions relevant to medical diagnostics and monitoring devices including pulse oximetry, blood pressure, near-infrared spectroscopy, non-invasive hemoglobin, carbon monoxide, met-hemoglobin, cerebral blood flow, respiratory rate and more. Our protocols are designed to generate data suitable for submission to the US Food and Drug Administration (FDA) and the International Organization for Standardization (ISO) for device approval. All studies are done with the institutional review board (IRB) approval of the UCSF Committee on Human Research.

Standard Pulse Oximeter Study

We determine the accuracy of pulse oximeters by exposing volunteers to short periods of low oxygen levels (75-100% SaO2) while monitoring how the oximeter responds. This helps us understand if these devices are accurate for everyone regardless of skin color during these low oxygen conditions.

Motion Testing

During pulse oximetry testing, we can include tools that mimic patient movements. These tools, which come from the manufacturer, are called motion fixtures. They help us simulate scenarios where a patient might be moving, allowing us to see how well the pulse oximeters perform in situations with motion during low oxygen conditions.

Carboxyhemoglobin Study

We assess pulse oximeters tailored for detecting carboxyhemoglobin (COHb), a hemoglobin type not carrying oxygen as usual. To ensure if pulse oximeters reliably detect elevated COHb levels during low-oxygen conditions, volunteers undergo brief low-oxygen exposure (75-100% SaO2) while we observe oximeter responses.

Methemoglobin Study

We assess pulse oximeters tailored for detecting methemoglobin (metHb), a hemoglobin type not carrying oxygen as usual. To ensure if pulse oximeters reliably detect elevated metHb levels during low-oxygen conditions, volunteers undergo brief low-oxygen exposure (75-100% SaO2) while we observe oximeter responses.

Low Perfusion Testing

With low perfusion testing, we can simulate low perfusion (reduced blood flow) using clamps or cuffs. We can also test in various body positions, like the Trendelenburg position. This allows us to examine how well devices perform under low oxygen conditions (75-100% SaO2) where blood flow may be limited or changed.

Cerebral Oximetry Study

We’re studying cerebral oximeters to gauge their accuracy in measuring brain oxygen levels. Comparing readings with direct blood measurements from the artery (SaO2) and jugular vein (SjvO2) helps us assess performance, particularly when arterial oxyhemoglobin saturation (SaO2) is between 70% and 100%.

Drug-Induced Apnea Testing

Using medications like Propofol and Remifentanil, we induce temporary breathing pauses (apneic events) to simulate opioid-related respiratory slowdown. The aim is to evaluate how effectively the oximeter combination can identify this reduced oxygen condition, crucial for monitoring patients in these specific medical situations.

Transcutaneous Carbon Dioxide Sensor Testing

We’re testing transcutaneous carbon dioxide sensors to see how well they monitor carbon dioxide levels in the blood. We’re examining their performance alone and when used with pulse oximetry and desaturation of oxyhemoglobin (a component of the blood that carries oxygen).

Neonatal Accuracy Testing

To ensure pulse oximeters work effectively in diverse scenarios, we test them on neonates undergoing heart surgery, where physiological conditions change. Multiple blood samples are taken, providing insights into oximeter performance amidst rapidly changing variables.

Profound Hemodilution Study

This study aims to assess the accuracy of new non-invasive pulse oximeters, measuring total blood hemoglobin without skin puncture. By temporarily removing and re-infusing blood in healthy volunteers (isovolemic hemodilution), we induce changes in hemoglobin concentration.

For each subject, we collect where they are overall on the Fitzpatrick scale. We also record their Monk scale for the following sites: fingernail, dorsal, palmar, inner/upper arm, forehead. Additionally, we collect objective skin pigment data from the same sites with a Konica Minolta Spectrophotometer CM-700d.

The sponsor is responsible for providing their pulse oximiters and placing them on the research subjects. They also must collect their device’s data and provide that to the lab after study completion (if requesting a report for FDA). If a sponsor would like other secondary data (eg. arm circumference, a different skin pigment scale), they should collect this data themselves with permission from the subjects. Sponsor staff must be present during the study.

The FDA requires that a validation study should have subjects with a range of skin pigmentations, including at least 2 darkly pigmented subjects or 15% of the subject pool depending on the study size. The Hypoxia Lab has traditionally used the Fitzpatrick scale to categorize skin pigment (see below). We aim to schedule 25% of the subjects in the Fitzpatrick V or VI range. For example, if we do a study with 12 subjects, 3 will be Fitzpatrick V or VI.

Clinical research is the way doctors and scientists learn about new ways to prevent and treat illness in people. Clinical research is the fastest way to find answers to the many questions about health and disease. It is sometimes called “human research” or a “clinical trial.”
At UCSF most research that needs human volunteers happens in hospitals and clinics. Other types of research studies take place in a doctor’s office, a treatment center, a nursing home, or a community clinic. Some studies involve asking questions in an office, by telephone, or even on the street or in a home.

There are different ways volunteers participate in clinical research. For example:

Volunteers participate by filling out questionnaires about their health, or they may answer questions about their health in an interview with researchers.
Volunteers may be asked to donate specimens such as a tube of blood or a tissue sample for a clinical research study.
Volunteers may participate in clinical research to find out if new treatments, or new ways of using known treatments, are safe and effective to use in people.

The faculty, staff and doctors at UCSF are dedicated to research and are deeply committed to finding new ways to prevent and treat illness and improve the health of patients who come to the University Medical Center for healthcare.

A typical study session lasts around 1 hour.

30-40 minutes of this time includes blood sample data collection and breathing on the circuit, while the remainder of the time is allocated to pre- and post-study tasks (i.e., signing the consent and skin color data collection beforehand, waiting ~10 minutes after study to apply pressure to wrist and ensure subject experiences no adverse effects).

According to the UCSF Institutional Review Board (IRB) website, an IRB is “a committee — operating under federal regulations, state laws and institutional policy — that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.”

All human subject research must be reviewed and approved by the IRB in order to be carried out. All of the Hypoxia Lab studies have received IRB approval prior to being conducted.

According to the World Health Organization’s (WHO) website, clinical trials are “a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.” This may include the testing of medical interventions such as “drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments and preventive care.

Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.”

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