Respiration From Pleth Validation
ConditionRespiratory Rate Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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 criteria
Qualifiers
Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Physiological Monitoring with SpO₂ Sensors and Capnography
Treatment groups
113 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov