Comparing oxygen saturation measurement methods in infants and children
Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients
This study is testing how well a new type of oxygen sensor works compared to traditional blood tests in babies and young children in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 560 (estimated) |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Trial ID | NCT06372106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include in-patients aged 18 years or older or parents/legal guardians of subjects under 18 years in neonatal or pediatric intensive care units.
Not a fit: Patients with known pregnancy, lactation, or compromised skin at sensor application sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of oxygen saturation measurements in vulnerable pediatric populations.
How similar studies have performed: Previous studies have shown varying success in evaluating pulse oximetry accuracy, but this specific approach focusing on skin pigmentation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.