Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Philips Clinical & Medical Affairs Global · NCT06372106
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 560
- US sites recruiting
- 5
- Study start
- April 4, 2024
- Record last updated
- April 2, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: SaO2 Sampling
Conditions: SpO2; Nasal Alar Collapse, Bilateral; Oxygen; Measurement
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Recruiting US locations
Phoenix Children's
Phoenix, AZ 85016
Site contact: Dana M Chan · 602-933-7143 · dchan@phoenixchildrens.com
University of Nebraska Medical Center
Omaha, NE 68114
Site contact: Sara M Jones, RD, LMNT · 402-559-1747 · saram.jones@unmc.edu
Duke University Medical Center
Durham, NC 27710
Site contact: Melissa Howard, MSCR · 919-668-3910 · Melissa.Harward@duke.edu
Medical University of South Carolina
Charleston, SC 29425
Site contact: Chanika Middleton · 843-792-0603 · middlech@musc.edu
Baylor College of Medicine
Houston, TX 77030
Site contact: Teresa Valenzuela · 832-824-6262 · Teresa.Valenzuela@bmc.edu
Study contacts (from the official record)
- Kelsey Rothwell · 984-480-7006 · Kelsey.Rothwell@philips.com
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