Physiological Monitoring with SpO₂ Sensors and Capnography
Physiological Monitoring with SpO₂ Sensors and Capnography: Participants will undergo noninvasive physiological monitoring with commercially available Philips SpO₂ sensors (adult finger sensor M1191T; pediatric finger glove M1192A; nasal alar sensors 989803205391; adult/pediatric ear sensor M1194A) connected to Philips MP5 or PM6300 patient monitors configured with standard FAST Pulse Oximetry technology. A LoFlo Sidestream etCO₂ sensor (M2741A) with an adult or pediatric oral/nasal cannula (989803206671 or 989803206681) will be used to collect reference capnography waveforms. All monitoring is observational, and no device output is used for clinical decision-making.
Study summary
This observational clinical investigation evaluates the performance of respiratory rate derived from the plethysmography waveform (Respiration from Pleth, RfP) using Philips FAST Pulse Oximetry technology. Adult and pediatric inpatients will undergo noninvasive monitoring using age- and weight-appropriate SpO₂ sensors and capnography, with capnography serving as the reference standard. The study assesses accuracy, mean bias, precision, and time to first valid respiratory-rate value across continuous and spot-check conditions. No device outputs are used for clinical decision-making, and all procedures occur during a single study visit.
Eligibility
Sex
ALL
Min age
4 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
2. UK Pediatric subjects:
* Aged 16 years and older willing and able to understand and provide written informed consent
* Aged 4-15 years and their legal guardians willing and able to understand and provide written informed consent/assent
3. US Pediatric Participants: aged 4 to 17 years and their parent/legal guardian are willing and able to understand and provide written informed assent/consent
4. Participant weight is within intended use of at least one SpO2 sensor under test as time of enrollment.
* M1191T, adult participants \> 50 kg
* M1192A, pediatric participants 15-50 kg
* Nasal Alar Sensor, adult and pediatric participants ≥ 15 kg
* M1194A, adult and pediatric participants \> 40 kg
5. Willing and able to wear study devices for the entirety of study procedures
6. Undergoing regular spot-check measurements as per the site's standard of care
Exclusion Criteria:
1. Palliative patients
2. Patients with tremors, cardiac pacemakers, or known atrial fibrillation
3. Patients receiving oxygen supplementation at the time of study participation
4. Critically ill patients with severe physiological instability
5. Pregnant and/or lactating patients (self-reported)
6. Injury, wounds, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear)
7. Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors
8. Unwillingness or inability to remove colored nail polish or artificial nails from the application site
9. Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites
10. Nail fungus on application site
11. Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
Primary outcome measure(s)
Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring — During the 20-minute continuous monitoring period for the finger sensor. Accuracy Root Mean Square (ARMS) between respiratory rate derived from plethysmography using Philips FAST Pulse Oximetry technology and respiratory rate derived from clinician-annotated capnography waveforms.
Metric: ARMS (breaths per minute). Pass/Fail Criterion: ARMS ≤ 3 BPM per population (adult, pediatric).
Trial sites (2)
Facility
City
Region
Status
Duke University Hospital
Durham
North Carolina
Recruiting
Ysbyty Gwynedd
Bangor
Gwynedd
Not Yet Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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