Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Recruiting now

Conditions studied: SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement

In brief

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.

Key facts

Study ID

NCT06372106

Run by

Philips Clinical & Medical Affairs Global

People needed

560

Starts

2024-04-04

Expected to finish

2025-12-01

Last updated by the study team

2025-04-02

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Phoenix Children's — Phoenix, Arizona, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Baylor College of Medicine — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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