Hand Perfusion and Pulse Oximetry Performance

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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.
• Процедура 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Mayo Clinic Department of Anesthesiology — Rochester

Идентификаторы

NCT: NCT06925646 · 25-001363

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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