Hand Perfusion and Pulse Oximetry Performance

Conditions

• Oxygen Saturation

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Sep 1, 2026

Status verified

Mar 2026

Primary completion

Oct 1, 2027

Completion

Oct 1, 2028

Study Design

Enrollment

20 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Arterial oxygen saturation measured via arterial blood gas sample (Sa02) [ Time Frame: 30 minutes, 90 minutes, 3 hours ]

Central Contacts

• Nancy Meyer
  5072550913
  [email protected]

Locations (1)

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