Respiration From Pleth Validation

NCT07449715 · tracked via the Priya Life Science UK tracker

Sponsor

Philips Clinical & Medical Affairs Global

Phase

Observational

Started

2026-02-06

Last updated

2026-03-04

Condition(s) studied

Respiratory Rate Monitoring

Investigational drug(s) / intervention(s)

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

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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Official registry record

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.

View NCT07449715 on ClinicalTrials.gov ↗ ← All trials in the UK