Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT06372106
Status
Recruiting
Apply to this trial

Conditions

  • Measurement
  • Nasal Alar Collapse, Bilateral
  • Oxygen
  • SpO2

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • SaO2 Sampling — DEVICE
    CO-Oximetry analysis of arterial blood samples

Study Details

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.

Key Dates

Start date
Apr 4, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
560 participants (estimated)

Arms

  • Arm: Neonates
    Even distribution of sex per skin pigmentation category (Light, Medium, Dark)
  • Arm: Infants
    Even distribution of sex per skin pigmentation category (Light, Medium, Dark)
  • Arm: Pediatrics
    Even distribution of sex per skin pigmentation category (Light, Medium, Dark)

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

Locations (5)

FacilityCityStateZIPSite coordinators
Phoenix Children'sPhoenixArizona85016
Dana M Chan
[email protected]
602-933-7143
University of Nebraska Medical CenterOmahaNebraska68114
Sara M Jones, RD, LMNT
[email protected]
402-559-1747
Duke University Medical CenterDurhamNorth Carolina27710
Melissa Howard, MSCR
[email protected]
919-668-3910
Medical University of South CarolinaCharlestonSouth Carolina29425
Chanika Middleton
[email protected]
843-792-0603
Baylor College of MedicineHoustonTexas77030
Teresa Valenzuela
[email protected]
832-824-6262

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Phoenix Children's· Phoenix, AZUniversity of Nebraska Medical Center· Omaha, NEDuke University Medical Center· Durham, NCMedical University of South Carolina· Charleston, SCBaylor College of Medicine· Houston, TX

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