Recruiting

Observational Study

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT06372106

Conditions

SpO2

Nasal Alar Collapse, Bilateral

Oxygen

Measurement

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

SaO2 Sampling

Study Details

Brief 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.

Conditions

SpO2

Nasal Alar Collapse, Bilateral

Oxygen

Measurement

Study ID

NCT06372106

Start date

Apr 4, 2024

Status verified date

Apr, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

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

Study Design

Enrollment

560 participants

Anticipated

Interventions and Outcome Measures

Arms

Neonates

Even distribution of sex per skin pigmentation category (Light, Medium, Dark)

Infants

Even distribution of sex per skin pigmentation category (Light, Medium, Dark)

Pediatrics

Even distribution of sex per skin pigmentation category (Light, Medium, Dark)

Interventions

SaO2 Sampling

CO-Oximetry analysis of arterial blood samples

Primary outcome measure

  • 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. [ Time Frame: through study completion, an average of 8 months ]

Central Contacts and Locations

Central contacts

Kelsey Rothwell

984-480-7006Kelsey.Rothwell@philips.com

Locations

Phoenix Children's

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Dana M Chan

602-933-7143dchan@phoenixchildrens.com

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Sara M Jones, RD, LMNT

402-559-1747saram.jones@unmc.edu

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Melissa Howard, MSCR

919-668-3910Melissa.Harward@duke.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Chanika Middleton

843-792-0603middlech@musc.edu

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Teresa Valenzuela

832-824-6262Teresa.Valenzuela@bmc.edu

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Apr 2, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2025-04-02.