Actively Recruiting
Respiration From Pleth Validation
Led by Philips Clinical & Medical Affairs Global · Updated on 2026-03-04
113
Participants Needed
2
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Respiration From Pleth Validation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older willing and able to provide written informed consent
- UK pediatric subjects aged 16 years and older willing and able to provide written informed consent
- UK pediatric subjects aged 4-15 years and their legal guardians willing and able to provide written informed consent/assent
- US pediatric participants aged 4 to 17 years and their parent or legal guardian willing and able to provide written informed assent/consent
- Participant weight within intended use of at least one SpO2 sensor at enrollment: M1191T adult > 50 kg, M1192A pediatric 15-50 kg, Nasal Alar Sensor ≥ 15 kg, M1194A > 40 kg
- Willing and able to wear study devices for the entire study procedures
- Undergoing regular spot-check measurements as per site's standard care
You will not qualify if you...
- 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, or physical malformation at sensor application sites (fingers, nose, ear)
- Severe contact allergies to adhesives, latex, or other pulse oximetry sensor materials
- Unwilling or unable to remove colored nail polish or artificial nails from application sites
- Unwilling or unable to remove foreign objects like nose or ear jewelry from sensor sites
- Nail fungus on application site
- Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
2
Ysbyty Gwynedd
Bangor, Gwynedd, United Kingdom, LL57 2PW
Not Yet Recruiting
Research Team
N
Nero Evero, Clinical Study Manager, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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