RECRUITING

Project Mountain - Comparing SpO2 and SaO2 for Accuracy

Conditions

SpO2 Nasal Alar Collapse, Bilateral Oxygen Measurement

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-04

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06372106

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.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Kelsey Rothwell

CONTACT

984-480-7006

Kelsey.Rothwell@philips.com

Principal Investigator

Amira Azer

STUDY_DIRECTOR

Philips Healthcare

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Philips Clinical & Medical Affairs Global

Amira Azer, STUDY_DIRECTOR, Philips Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04

Study Completion Date2024-12

Study Record Updates

Study Start Date2024-04-04

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

SpO2
Nasal Alar Collapse, Bilateral
Oxygen
Measurement