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Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
To validate SpO2 accuracy performance of various SpO2 sensors with the Philips FAST Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | No interventions, single group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Device | There is no intervention in this study |
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| Measure | Description | Time Frame |
|---|---|---|
| Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053 | 13DEC2022-Q3 2023 |
| Measure | Description | Time Frame |
|---|---|---|
| Over 70-100% SpO2, an ARMS of ≤ 3% in non-motion conditions for the following SpO2 Sensors: 989803128591, 989803205881, 989803205891, 989803205911, 989803205831, 989803205381, MAXAI, MAXNI, OxySoftN, 4004, and 4052 | Over 70-100% SpO2, an ARMS of ≤ 2% in non-motion conditions for the following SpO2 Sensors: 989803144381, 989803205851, 4000, 4050, and 2258 • Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter Over 70-100% SpO2, an ARMS within 1% among the broad categories of light, medium, and dark skin pigmentation for each SpO2 sensor under test Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter) |
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Inclusion Criteria:
Subject must have the ability to understand and provide written informed consent
Exclusion Criteria:
Novocaine) Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio < 0.4) Unwillingness or inability to remove colored nail polish from test digits. Dye injection within the past 48 hours Other known health condition, should be considered upon disclosure in health assessment form Dysfunctional hemoglobin levels
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The population will include healthy non-smoking (or refrained from smoking for 2 days) competent adults, 18-50 yrs of age. It is planned that a sufficient number of participants will be screened to enroll in order to collect a minimum of 200 data points per sensor between 60 completed participants. Enrolled participants will be separated into 2 test groups of 30 completed participants. Each test group will consist of a minimum of 10 participants, with a min. of 3 males and 3 females, per each broad skin pigmentation category of light, medium, and dark.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark | Louisville | Colorado | 80027 | United States |
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| 20DEC2022 - Q3 2023 |