Project Mountain - Comparing SpO2 and SaO2 for Accuracy

NCT06372106 | Recruiting FDA Device

• 1 other identifier: MA_PM_Mountain_2022_11496
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

  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.

  through study completion, an average of 8 months

Study Arms (3)

Neonates

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

Device: SaO2 Sampling

Infants

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

Device: SaO2 Sampling

Pediatrics

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

Device: SaO2 Sampling

Interventions

SaO2 Sampling DEVICE

CO-Oximetry analysis of arterial blood samples

Infants; Neonates; Pediatrics

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (5)

Phoenix Children's

Phoenix, Arizona, 85016, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Nasal Alar Collapse, Bilateral

Study Officials

• Amira Azer

  Philips Healthcare

  STUDY DIRECTOR

Central Study Contacts

Kelsey Rothwell

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 17, 2024
• Study Start: April 4, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)