Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters

Study Overview
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Brief Summary
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This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.

Official Title
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Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters

Conditions
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Healthy

Intervention / Treatment
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* Device: INVSENSOR00050
* Device: RD SET SpO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 to 50 years of age. Subject weighs a minimum of 110 lbs. Subject has a hemoglobin value ≥ 11 g/dL. Subject's baseline heart rate is ≥ 45 bpm and ≤ 85 bpm. Subject's CO value is ≤ 2.0% FCOHb. Subject's blood pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test. Subject is able to read and communicate in English and understands the study and the risks involved. Exclusion Criteria: Subject is pregnant. Subject has a BMI > 35. Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws. Subject has open wounds, inflamed tattoos or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation.* Subject has known drug or alcohol abuse. Subject uses recreational drugs.* Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound. Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months. Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures. Subject has any chronic bleeding disorder (e.g. hemophilia). Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)). Subject has donated blood within the past 4 weeks. Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome. Subject has any symptomatic cardiac dysrhythmia (e.g. atrial fibrillation) and has not received clearance from their physician to participate. Subject has a known neurological and/or psychiatric disorder (e.g. schizophrenia, bipolar disorder, multiple sclerosis, Huntington's disease) that interferes with the subject's level of consciousness.* Subject has taken opioid pain medication 24 hours before the study. Subject has any active signs and/or symptoms of infectious disease (e.g. hepatitis, HIV, tuberculosis, flu, malaria, measles, etc.).* Subject is taking medications known to treat any type of infectious disease. Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome. Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery.* Subject has symptoms of congestion, head cold, or other illnesses. Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months. Subject has any cancer or history of cancer (not including skin cancer).* Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease. Subject is allergic to lidocaine, chlorhexidine, latex, adhesives, or plastic. Subject has a heart condition, insulin-dependent diabetes, or uncontrolled hypertension. Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the past 6 months. Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (working out, riding a bike, riding a skateboard, etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line. Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of the investigator/study staff).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulse oximeters<br>All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors. | Device: INVSENSOR00050<br>* Noninvasive pulse oximeter sensor<br>Device: RD SET SpO2<br>* Noninvasive pulse oximeter sensor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050 | Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin. | 1-5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor | The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1% SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05. | 1-5 hours | 
| Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors | The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05. | 1-5 hours |