Actively Recruiting
Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Led by Philips Clinical & Medical Affairs Global · Updated on 2025-04-02
560
Participants Needed
5
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent.
- Weight and/or age within intended use of at least one SpO2 sensor under test at time of enrollment.
- Willing and able to wear study devices in addition to SoC devices and during SoC procedures.
- In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU, PCICU).
- Has arterial access and ability to have arterial blood samples drawn as part of their SoC and analyzed by CO-Oximetry.
You will not qualify if you...
- Known pregnancy or lactating females (self-reported)
- Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). Note: Certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system.
- Self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. Note: Subject may be considered eligible if subject can wear non-adhesive sensor.
- Unwillingness or inability to remove nail polish or artificial nails from sensor application site.
- Nail fungus on sensor application site.
- Wearing and unable to remove jewelry from sensor application site.
- Dye injection within 48 hours of enrollment.
- Known dysfunctional hemoglobin levels (COHb >3%, MetHb >2%, and ctHb <10g/dl)
- Undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Phoenix Children's
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kelsey Rothwell
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here