SpO2NCT06372106
Project Mountain - Comparing SpO2 and SaO2 for Accuracy
An observational study of SpO2 and Nasal Alar Collapse, Bilateral, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen
- What is being tested?
- SaO2 Sampling
- Type of treatment
- Medical device
- How many people
- 560 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Apr 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Chanika Middleton, 843-792-0603, middlech@musc.edu
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Melissa Howard, MSCR, 919-668-3910, Melissa.Harward@duke.edu
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Teresa Valenzuela, 832-824-6262, Teresa.Valenzuela@bmc.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Sara M Jones, RD, LMNT, 402-559-1747, saram.jones@unmc.edu
- Recruiting
Phoenix Children's
Phoenix, Arizona, 85016
Dana M Chan, 602-933-7143, dchan@phoenixchildrens.com
About this study
Official title: Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients
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.
Read the detailed description
This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Being tested
- SaO2 Sampling
- Medical subject headings
- Nasal Alar Collapse, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaO2 SamplingDevice
CO-Oximetry analysis of arterial blood samples
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) Receives: Device: SaO2 Sampling | |
| Infants | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) Receives: Device: SaO2 Sampling | |
| Pediatrics | Even distribution of sex per skin pigmentation category (Light, Medium, Dark) Receives: Device: SaO2 Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start4 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpO2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amira Azer, Study director, Philips Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372106
- Sponsor's protocol ID
- MA_PM_Mountain_2022_11496
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients
- ClinicalTrials.gov ID
- NCT06372106
- Acronym / sponsor ID
- MA_PM_Mountain_2022_11496
- Conditions
- SpO2, Nasal Alar Collapse, Bilateral, Oxygen, Measurement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonates | – | Device: SaO2 SamplingEven distribution of sex per skin pigmentation category (Light, Medium, Dark) |
| Infants | – | Device: SaO2 SamplingEven distribution of sex per skin pigmentation category (Light, Medium, Dark) |
| Pediatrics | – | Device: SaO2 SamplingEven distribution of sex per skin pigmentation category (Light, Medium, Dark) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaO2 SamplingCO-Oximetry analysis of arterial blood samples | Device | Infants, Neonates, Pediatrics |
Primary outcome
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
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.
2 secondary outcomes
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.
Time frame: 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.
Time frame: through study completion, an average of 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amira Azer study director
Philips Healthcare
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SpO2 and Nasal Alar Collapse, Bilateral, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelsey Rothwell (984-480-7006, Kelsey.Rothwell@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.