Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Study Overview
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Brief Summary
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Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.

Official Title
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Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Conditions
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Healthy

Intervention / Treatment
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* Device: INVSENSOR00069


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Influenced by study design: Subject is 18 to 50 years of age. Subject weighs a minimum of 110 lbs. Hemoglobin value ≥ 11 g/dL. Baseline heart rate ≥ 45 bpm and ≤ 90 bpm. Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test. CO value ≤ 3.0% FCOHb. Subject is comfortable to read and communicate in English*. *This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures. Exclusion Criteria: Influenced by device warning labels: Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.). Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them. Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease). Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease). Influenced by study design/environment: Subjects who do not pass the health assessment for safe participation in the study procedures. Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.

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: Test Subject<br>All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. | Device: INVSENSOR00069<br>* Noninvasive pulse oximeter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral oxygen saturation (SpO2) accuracy of INVSENSOR00069 | Accuracy of INVSENSOR00069 will be determined by calculating the root mean square (ARMS) value through comparison of the peripheral oxygen saturation measurement (SpO2) of INVSENSOR00069 against contemporaneous measurements from arterial blood gas (ABG) analysis (SaO2). | 1-3 hours |