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Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Philips Clinical & Medical Affairs Global · NCT06372106

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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
Project Mountain - Comparing SpO2 and SaO2 for Accuracy (NCT06372106) | Bored Studies