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.
Study Type
OBSERVATIONAL
Enrollment
560
CO-Oximetry analysis of arterial blood samples
Phoenix Children's
Phoenix, Arizona, United States
RECRUITINGUniversity of Nebraska Medical Center
Omaha, Nebraska, United States
RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGBaylor College of Medicine
Houston, Texas, United States
RECRUITINGTo 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.
Time frame: through study completion, an average of 8 months
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.
Time frame: through study completion, an average of 8 months
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.
Time frame: through study completion, an average of 8 months
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