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
This trial does not accept healthy volunteersQualifiers
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 population
Hospitalized, spontaneously breathing adult and pediatric inpatients receiving spot-check vital-sign monitoring as part of routine clinical care, who meet all inclusion criteria and no exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physiological Monitoring with SpO₂ Sensors and Capnography
DeviceParticipants will undergo noninvasive physiological monitoring with commercially available Philips SpO₂ sensors (adult finger sensor M1191T; pediatric finger glove M1192A; nasal alar sensors 989803205391; adult/pediatric ear sensor M1194A) connected to Philips MP5 or PM6300 patient monitors configured with standard FAST Pulse Oximetry technology. A LoFlo Sidestream etCO₂ sensor (M2741A) with an adult or pediatric oral/nasal cannula (989803206671 or 989803206681) will be used to collect reference capnography waveforms. All monitoring is observational, and no device output is used for clinical decision-making.
Treatment groups
113 Participants
are divided into 2 treatment groupsGroup A: Adult Inpatients1 intervention
Group B: Pediatric Inpatients1 intervention
Trial outcomes
Primary outcomes
1
Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring
Accuracy Root Mean Square (ARMS) between respiratory rate derived from plethysmography using Philips FAST Pulse Oximetry technology and respiratory rate derived from clinician-annotated capnography waveforms. Metric: ARMS (breaths per minute). Pass/Fail Criterion: ARMS ≤ 3 BPM per population (adult, pediatric).
Time frame
During the 20-minute continuous monitoring period for the finger sensor.Secondary outcomes
1
Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)
ARMS comparing pleth-derived RR with annotated capnography for alar, ear, and pooled sensors.
Time frame
20-minute continuous monitoring period.2
Mean Bias - All Sensor Types (Continuous Monitoring)
Mean difference (pleth RR - reference RR) per sensor type and pooled. Pass/Fail Criterion: Mean bias between -1 and +1 BPM.
Time frame
20-minute continuous monitoring.3
Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)
Standard deviation of pleth-derived RR error relative to capnography.
Time frame
20-minute continuous monitoring.4
Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)
ARMS during the first 5 minutes ("spot-check window") compared with capnography.
Time frame
0-5 minutes after sensor connection (spot-check period).Sponsors and contacts
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Source ClinicalTrials.gov