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Not yet recruiting NCT06925646

Hand Perfusion and Pulse Oximetry Performance

— Observational Oxygen Saturation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Finger hyperperfusion via adenosine, Finger hypoperfusion via by norepinephrine, Baseline hypoxic test.
Who it may be relevant to
Registry conditions: Oxygen Saturation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 bloo
  • 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.

Primary outcome measures

  • Arterial oxygen saturation measured via arterial blood gas sample (Sa02) [Time frame: 30 minutes, 90 minutes, 3 hours]
  • Arterial oxygen saturation measured via pulse oximeters (Sp02) [Time frame: 30 minutes, 90 minutes, 3 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic Department of Anesthesiology — Rochester

Identifiers

NCT: NCT06925646 · 25-001363

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗