Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Condition
SpO2
Intervention / Treatment

-

Contacts and Locations

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Philips Clinical & Medical Affairs Global,

Amira Azer, STUDY_DIRECTOR, Philips Healthcare

Study Record Dates

2024-12