Comparing oxygen saturation measurement methods in infants and children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the accuracy of Philips SpO2 sensors against invasive arterial oxygen measurements in neonatal, infant, and pediatric populations. It will collect data on various demographic factors, including skin pigmentation, to understand their impact on measurement accuracy. Participants will be in-patients in neonatal or pediatric intensive care units and will have arterial access for blood sampling. The study is designed to be multi-center and will analyze data descriptively based on the performance of the sensors used.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Kelsey Rothwell
• Email: Kelsey.Rothwell@philips.com
• Phone: 984-480-7006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.