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NCT Number: NCT06925646

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.

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Key information

Conditions

Oxygen Saturation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Department of Anesthesiology

Rochester, Minnesota, 55902, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Finger hyperperfusion via adenosine

Procedure

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

Procedure

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

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Meyer

CONTACT

[email protected]

5072550913

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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