Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
20 participants
OBSERVATIONAL
2026-02-01
2028-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Finger hyperperfusion via adenosine
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 norepinephrine
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 test
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.
Interventions
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Finger hyperperfusion via adenosine
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 norepinephrine
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 test
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Free of cardiopulmonary diseases or other conditions and/or taking medications that might affect pulse oximeter-based estimates of arterial saturation.
Exclusion Criteria
• 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Michael J. Joyner, M.D.
Principal Investigator
Principal Investigators
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Michael Joyner, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Department of Anesthesiology
Rochester, Minnesota, United States
Countries
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Central Contacts
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Other Identifiers
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25-001363
Identifier Type: -
Identifier Source: org_study_id