Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Oxygen; SpO2; Nasal Alar Collapse, Bilateral; Measurement
• Intervention / Treatment: Device: SaO2 Sampling

Detailed Description

This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.

• Study Type: Observational
• Enrollment (Estimated): 560

Contacts and Locations

• Study Contact: Name: Kelsey Rothwell; Phone Number: 984-480-7006; Email: Kelsey.Rothwell@philips.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Phoenix Children's
      • Contact: Dana M Chan; Phone Number: 602-933-7143; Email: dchan@phoenixchildrens.com
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Sara M Jones, RD, LMNT; Phone Number: 402-559-1747; Email: saram.jones@unmc.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Melissa Howard, MSCR; Phone Number: 919-668-3910; Email: Melissa.Harward@duke.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Chanika Middleton; Phone Number: 843-792-0603; Email: middlech@musc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Teresa Valenzuela; Phone Number: 832-824-6262; Email: Teresa.Valenzuela@bmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonates; Even distribution of sex per skin pigmentation category (Light, Medium, Dark)	Device: SaO2 Sampling; CO-Oximetry analysis of arterial blood samples
Infants; Even distribution of sex per skin pigmentation category (Light, Medium, Dark)	Device: SaO2 Sampling; CO-Oximetry analysis of arterial blood samples
Pediatrics; Even distribution of sex per skin pigmentation category (Light, Medium, Dark)	Device: SaO2 Sampling; CO-Oximetry analysis of arterial blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	through study completion, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology.	Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology.	through study completion, an average of 8 months
Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation.	Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation.	through study completion, an average of 8 months

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Study Director: Amira Azer, Philips Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: MA_PM_Mountain_2022_11496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No