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This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.
Testing should require approximately an hour and 15 minutes of the participant's time.
Several separate cohorts of study participants will be recruited and enrolled in accordance with laboratory time and staff availability. After informed consent is performed, a local anesthetic will be injected around the radial artery, and a 22-gauge radial artery catheter will be placed. Pulse oximeters/sensors under test will be attached to the subject along with FDA-cleared reference pulse oximeters. ECG electrodes will be placed on the subject to monitor the subject's heart rate. The Owlet Sensor under test placement and serial numbers will be documented for each subject. Subjects will be placed in a seated, semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia.
Each subject will undergo two cycles of three different hypoxia plateaus in the 90-100%, 80-90% and 70-80% range, with an average of 20-24 data pairs with a maximum range of 17-30 data points. Study subjects may be have a motion protocol applied to test the Owlet Sensor's accuracy during variable frequencies and amplitudes of movement.
The motions applied by the motion simulator will be 1) 2 Hz sine 10mm 2) 3 Hz sine 10mm 3) 4 Hz sine 10mm 4 ) Random motion 30mm peak, 20 to 200 mm / sec These motions are applied with the fingers tapping on the first cycle of hypoxia and rubbing on the second cycle. The subject will not perform the motion during the first blood sample of each plateau but will during the 2-4th samples separated by 30 seconds.
90% of participants will have at least one usable data point below 85% and at least 69% of subjects will have one usable data pair between 70-80%. As this procedure is evaluating a single user device, a new sensor will be applied to each study participant.
The skin tone distribution of subjects will be divided into 3 groups based on the 10 point Monk skin tone scale (MST) and Individual Typology Angle (ITA) measured by an ISO compliant colorimeter at the forehead and at the anatomic location of sensor placement. MST will be assessed with a printed color swatch that has been verified by a colorimeter. Enrollment of subjects must follow these criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoxia Plateau Protocol | Experimental | Study participants that all undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse oximeter accuracy under hypoxic conditions | Diagnostic Test | This study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Oximeter Accuracy Measures |
| From enrollment to completion of 6 plateaus of hypoxia over an approximate 75 minute period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koa Gudelunas | Vital Signs Research Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vital Signs Research Group | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38046737 | Background | Cohen PR, DiMarco MA, Geller RL, Darrisaw LA. Colorimetric Scale for Skin of Color: A Practical Classification Scale for the Clinical Assessment, Dermatology Management, and Forensic Evaluation of Individuals With Skin of Color. Cureus. 2023 Nov 1;15(11):e48132. doi: 10.7759/cureus.48132. eCollection 2023 Nov. | |
| 15791098 | Background |
| Label | URL |
|---|---|
| A guide to the skin tone stratification used for assessment of accuracy across all represented populations. | View source |
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Data collected during the course of this study are specifically intended for a regulatory submission and may or may not be shared publicly.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bickler PE, Feiner JR, Severinghaus JW. Effects of skin pigmentation on pulse oximeter accuracy at low saturation. Anesthesiology. 2005 Apr;102(4):715-9. doi: 10.1097/00000542-200504000-00004. |
| 34772785 | Background | Okunlola OE, Lipnick MS, Batchelder PB, Bernstein M, Feiner JR, Bickler PE. Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. Respir Care. 2022 Feb;67(2):252-257. doi: 10.4187/respcare.09795. Epub 2021 Nov 12. |
| 33326721 | Background | Sjoding MW, Dickson RP, Iwashyna TJ, Gay SE, Valley TS. Racial Bias in Pulse Oximetry Measurement. N Engl J Med. 2020 Dec 17;383(25):2477-2478. doi: 10.1056/NEJMc2029240. No abstract available. |