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The objective of this study is to verify the form, fit and function of the Philips FAST technology with Masimo neonatal, infant and pediatric sensors for SpO2 monitoring in the respective indicated populations. The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient populations that have a range of different skin pigmentations, simultaneously with an FDA cleared pulse oximeter as a comparator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm | Experimental | All subjects are enrolled into this arm. All subjects will have blood oxygen measurements from:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm | Device | Subjects may use multiple Masimo sensors (RD SET and/or LNCS). All subjects will have at least one Masimo sensor (RD SET or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm |
| Measure | Description | Time Frame |
|---|---|---|
| The acceptability of the quality of SpO2 signal obtained during non-invasive oxygen saturation monitoring using Philips FAST SpO2 technology with Masimo neonatal, infant, and pediatric sensors. Accuracy root mean square (ARMS) will be calculated. | 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| The acceptability of the fit of sensor by visual observation of the emitter and detector alignment. | 45 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Contact | 949-297-7000 | clinicalresearchdept@masimo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradigm Clinical Research | Recruiting | Modesto | California | 95355 | United States |
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| Paradigm Clinical Research | Recruiting | San Diego | California | 92108 | United States |
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