Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Not Applicable

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Test Subject	INVSENSOR00069	All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.

Primary Outcome Measures

Name	Time	Method
SpO2 Accuracy of Masimo INVSENSOR00069	1-3 hours	The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2_i-SaO2_i )\^2 ))/n.

Secondary Outcome Measures