Project Mountain - Comparing SpO2 and SaO2 for Accuracy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
SaO2 Sampling
DeviceCO-Oximetry analysis of arterial blood samples
Treatment groups
560 Participants
are divided into 3 treatment groupsGroup A: Neonates1 intervention
Group B: Infants1 intervention
Group C: Pediatrics1 intervention
Trial outcomes
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.
Time frame
through study completion, an average of 8 monthsSecondary outcomes
1
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.
Time frame
through study completion, an average of 8 months2
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.
Time frame
through study completion, an average of 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov