Hand Perfusion and Pulse Oximetry Performance

Mayo Clinic

Status: Not yet enrolling

Conditions: Oxygen Saturation

Treatments: Procedure: Finger hyperperfusion via adenosine; Procedure: Finger hypoperfusion via by norepinephrine; Procedure: Baseline hypoxic test

Study type: Observational

Funder types: Other

Identifiers

NCT06925646

25-001363

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

Study group

Description:

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.

Treatment:

Procedure: Baseline hypoxic test

Procedure: Finger hypoperfusion via by norepinephrine

Procedure: Finger hyperperfusion via adenosine