Oxygen SaturationNCT06925646
Hand Perfusion and Pulse Oximetry Performance
An observational study of Oxygen Saturation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Finger hyperperfusion via adenosine, Finger hypoperfusion via by norepinephrine and Baseline hypoxic test
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
Who may be able to join
- Healthy adult men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
- Equal number of male and female participants to address potential sex differences in physiology.
- We will intentionally recruit subjects with dark skin because of the issues surrounding accuracy of pulse oximetry and skin tone.
- Non-smokers
- BMIs between 18-30 kg·m-2.
- Female subjects will be non-pregnant.
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- Free of cardiopulmonary diseases or other conditions and/or taking medications that might affect pulse oximeter-based estimates of arterial saturation.
- All inclusion and exclusion criteria are at the discretion of the Principal Investigator.
- At least 8 of the subjects will have Fitzpatrick Skin Type of IV to VI.
Who cannot join
- Children under the age of 18 will not be studied. We will exclude children less than 18 years of age because they are unable to give consent, and because these studies are non-therapeutic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic Department of Anesthesiology
Rochester, Minnesota, 55902
About this study
The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements.
- Conditions
- Oxygen Saturation
- Being tested
- Finger hyperperfusion via adenosine, Finger hypoperfusion via by norepinephrine, Baseline hypoxic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger hyperperfusion via adenosineProcedure or surgery
Subjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each.
Blood flow to the hand downstream from the brachial catheter will be increased by brachial artery infusions of adenosine administered at 6.25 mcg/100ml tissue per minute for 30 minutes into the brachial artery to increase blood flow by 5 to 10-fold.
Finger hypoperfusion via by norepinephrineProcedure or surgery
Subjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each.
Blood flow to the hand downstream from the brachial catheter will be decreased to ~25% of baseline, by infusing norepinephrine at 4 ng/100ml of tissue per minute for 30 minutes.
Baseline hypoxic testProcedure or surgery
Subjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study group will consist of 20 healthy non-smokers, with BMIs between 18-30 kg·m-2, free of cardiopulmonary diseases.
Subjects will wear multiple pulse oximeter devices to measure arterial oxygen saturation (SpO2).
Two fingers of each hand will be be equipped with identical FDA approved devices from two different commercial manufacturers.
The third finger of each hand be equipped with a Mayo device developed by the SPPDG program for use by the US Military.
Two wrist worn PPG-equipped "watches" (Garmin Fenix and the Mayo Clinic Developed SPPDG Watch) will be worn on each arm. One will be placed in the normal watch position (dorsal forearm) where pigmentation will generally be the darkest; the other will be placed on the volar forearm where pigmentation is generally less.
Subjects will also have an indwelling catheter placed in the brachial artery to collect samples for blood gases. Receives: Procedure: Finger hyperperfusion via adenosine; Procedure: Finger hypoperfusion via by norepinephrine; Procedure: Baseline hypoxic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen saturation measured via arterial blood gas sample (Sa02)
Arterial oxygen saturation will be obtained via a blood sample at the end of each stage of the breath down protocols and is reported as a percentage.
Measured: 30 minutes, 90 minutes, 3 hours
Arterial oxygen saturation measured via pulse oximeters (Sp02)
Arterial oxygen saturation will be obtained via pulse oximeter reading at the end of each stage of the breath down protocols and is reported as a percentage.
Measured: 30 minutes, 90 minutes, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Joyner, M.D., Mayo Clinic
- Investigators
- Michael Joyner, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925646
- Sponsor's protocol ID
- 25-001363
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Perfusion and Pulse Oximetry Performance
- ClinicalTrials.gov ID
- NCT06925646
- Acronym / sponsor ID
- 25-001363
- Conditions
- Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare oxygen saturation measurement readings from manufactured pulse oximetry devices to the oxygen saturation measurements of arterial blood samples drawn at the same time of measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Finger hyperperfusion via adenosine, Procedure: Finger hypoperfusion via by norepinephrine, Procedure: Baseline hypoxic testThe study group will consist of 20 healthy non-smokers, with BMIs between 18-30 kg·m-2, free of cardiopulmonary diseases. Subjects will wear multiple pulse oximeter devices to measure arterial oxygen saturation (SpO2). Two fingers of each hand will be be equipped with identical FDA approved devices from two different commercial manufacturers. The third finger of each hand be equipped with a Mayo device developed by the SPPDG program for use by the US Military. Two wrist worn PPG-equipped "watches" (Garmin Fenix and the Mayo Clinic Developed SPPDG Watch) will be worn on each arm. One will be placed in the normal watch position (dorsal forearm) where pigmentation will generally be the darkest; the other will be placed on the volar forearm where pigmentation is generally less. Subjects will also have an indwelling catheter placed in the brachial artery to collect samples for blood gases. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
Key inclusion criteria (9 listed)
- Healthy adult men and women of all races and ethnic backgrounds recruited from faculty and staff of the Mayo Medical Center and from Rochester, MN and surrounding communities.
- Equal number of male and female participants to address potential sex differences in physiology.
- We will intentionally recruit subjects with dark skin because of the issues surrounding accuracy of pulse oximetry and skin tone.
- Non-smokers
- BMIs between 18-30 kg·m-2.
Key exclusion criteria (1 listed)
- Children under the age of 18 will not be studied. We will exclude children less than 18 years of age because they are unable to give consent, and because these studies are non-therapeutic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finger hyperperfusion via adenosineSubjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each. Blood flow to the hand downstream from the brachial catheter will be increased by brachial artery infusions of adenosine administered at 6.25 mcg/100ml tissue per minute for 30 minutes into the brachial artery to increase blood flow by 5 to 10-fold. | Procedure or surgery | Study group |
| Finger hypoperfusion via by norepinephrineSubjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each. Blood flow to the hand downstream from the brachial catheter will be decreased to ~25% of baseline, by infusing norepinephrine at 4 ng/100ml of tissue per minute for 30 minutes. | Procedure or surgery | Study group |
| Baseline hypoxic testSubjects will be fitted with a mouthpiece and/or facemask to systematically reduce the fraction of inspired oxygen (FiO2) they breathe, starting with room air (21% O2), and then progressive hypoxic mixtures of 18%, 15%, 12%, and 10% FiO2 in sequence for five minutes each. | Procedure or surgery | Study group |
Primary outcome
Arterial oxygen saturation measured via arterial blood gas sample (Sa02)
Time frame: 30 minutes, 90 minutes, 3 hours
Arterial oxygen saturation will be obtained via a blood sample at the end of each stage of the breath down protocols and is reported as a percentage.
Arterial oxygen saturation measured via pulse oximeters (Sp02)
Time frame: 30 minutes, 90 minutes, 3 hours
Arterial oxygen saturation will be obtained via pulse oximeter reading at the end of each stage of the breath down protocols and is reported as a percentage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Joyner, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Meyer (5072550913, meyer.nancy2@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen saturation measured via arterial blood gas sample (Sa02) (time frame: 30 minutes, 90 minutes, 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.