Respiration From Pleth Validation (NCT07449715) | Clinical Trial Compass
RecruitingNot Applicable
Respiration From Pleth Validation
United States, United Kingdom113 participantsStarted 2026-02-06
Plain-language 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 SpOâ‚‚ 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.
Who can participate
Age range4 Years
SexALL
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Inclusion criteria
✓. Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
✓. UK Pediatric subjects:
✓. 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.
✓. 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
Exclusion criteria
✕. Palliative patients
✕. Patients with tremors, cardiac pacemakers, or known atrial fibrillation
✕. Patients receiving oxygen supplementation at the time of study participation