Ireland
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Recruiting Observational

Project Mountain - Comparing SpO2 and SaO2 for Accuracy

NCT06372106 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2024-04-04
Last updated
2025-04-02

Condition(s) studied

SpO2Nasal Alar Collapse, BilateralOxygenMeasurement

Investigational drug(s) / intervention(s)

SaO2 Sampling

SaO2 Sampling: CO-Oximetry analysis of arterial blood samples

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. — through study completion, an average of 8 months
    The oximetry technology will be expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth.

Trial sites (5)

FacilityCityRegionStatus
Phoenix Children's Phoenix Arizona Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Duke University Medical Center Durham North Carolina Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Baylor College of Medicine Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06372106 on ClinicalTrials.gov ↗ ← All trials in the USA