💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Physiological Monitoring with SpO₂ Sensors and Capnography
Duke University Hospital
Durham, United States
Ysbyty Gwynedd
Bangor, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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