Hand Perfusion and Pulse Oximetry Performance

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

At least 8 of the subjects will have Fitzpatrick Skin Type of IV to VI.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Finger hyperperfusion via adenosine

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Study group3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
30 minutes, 90 minutes, 3 hours
2

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.

Time frame
30 minutes, 90 minutes, 3 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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