Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Start Date
4/4/2024
Completion Date
12/1/2025
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
SaO2 Sampling
Conditions
Locations
Phoenix Children's
Phoenix, Arizona 85016
United States
University of Nebraska Medical Center
Omaha, Nebraska 68114
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Baylor College of Medicine
Houston, Texas 77030
United States