Respiration From Pleth Validation
Recruiting now
Conditions studied: Respiratory Rate Monitoring
In brief
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.
Key facts
- Study ID
- NCT07449715
- Run by
- Philips Clinical & Medical Affairs Global
- People needed
- 113
- Starts
- 2026-02-06
- Expected to finish
- 2026-05-25
- Last updated by the study team
- 2026-03-04
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
- 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
- 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
- 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
- Willing and able to wear study devices for the entirety of study procedures
- Undergoing regular spot-check measurements as per the site's standard of care
You may not qualify if…
- Palliative patients
- Patients with tremors, cardiac pacemakers, or known atrial fibrillation
- Patients receiving oxygen supplementation at the time of study participation
- Critically ill patients with severe physiological instability
- Pregnant and/or lactating patients (self-reported)
- Injury, wounds, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear)
- Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors
- Unwillingness or inability to remove colored nail polish or artificial nails from the application site
- Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites
- Nail fungus on application site
- Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
Where it is running
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
- Ysbyty Gwynedd — Bangor, Gwynedd, United Kingdom
Full record on ClinicalTrials.gov
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