Hand Perfusion and Pulse Oximetry Performance

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 Overview

• Status: Not yet recruiting
• Conditions: Oxygen Saturation
• Intervention / Treatment: Procedure: Finger hyperperfusion via adenosine; Procedure: Finger hypoperfusion via by norepinephrine; Procedure: Baseline hypoxic test

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Nancy Meyer; Phone Number: 5072550913; Email: meyer.nancy2@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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.
• 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.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Procedure: 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.; Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 minutes, 90 minutes, 3 hours

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Michael Joyner, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Analgesics; Neurotransmitter Agents; Anti-Arrhythmia Agents; Purinergic Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Vasodilator Agents; Sympathomimetics; Vasoconstrictor Agents; Purinergic P1 Receptor Agonists; Purinergic Agonists; Norepinephrine; Adenosine
• Other Study ID Numbers: 25-001363

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No