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The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.
This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) |
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| Infants | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) |
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| Pediatrics | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SaO2 Sampling | Device | CO-Oximetry analysis of arterial blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. | The oximetry technology will be expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. | through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. | Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. | through study completion, an average of 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelsey Rothwell | Contact | 984-480-7006 | Kelsey.Rothwell@philips.com |
| Name | Affiliation | Role |
|---|---|---|
| Amira Azer | Philips Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's | Recruiting | Phoenix | Arizona | 85016 | United States |
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| ID | Term |
|---|---|
| C563533 | Nasal Alar Collapse, Bilateral |
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| Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. | Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. | through study completion, an average of 8 months |
| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68114 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
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| Baylor College of Medicine | Recruiting | Houston | Texas | 77030 | United States |
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