Respiratory Rate MonitoringRfP ValidationNCT07449715
Respiration From Pleth Validation
An observational study of Respiratory Rate Monitoring, run by Philips Clinical & Medical Affairs Global at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Respiratory Rate Monitoring
- What is being tested?
- Physiological Monitoring with SpO₂ Sensors and Capnography
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 113 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Feb 2026to 25 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent
- 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
- 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.
Show all 12Show fewer
- 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
- 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
Who cannot join
- 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, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear)
Show all 11Show fewer
- Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors
- Unwillingness or inability to remove colored nail polish or artificial nails from the application site
- Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites
- Nail fungus on application site
- Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
David MacLeod, Associate Professor of Anesthesiology, MBBS, 919-681-6437, david.macleod@duke.edu
David MacLeod, MBBS
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Ysbyty Gwynedd
Bangor, Gwynedd, LL57 2PW
Manohar Joishy, Clinical Director, Paediatrics, MD, +44 03000 841 295, manohar.joishy@wales.nhs.uk
Manohar Joishy, MD
About this study
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.
Read the detailed description
Respiratory rate is a key clinical vital sign and an early indicator of patient deterioration, but traditional manual counting is often inaccurate and inconsistently performed. Prior research has demonstrated that respiratory rate can be derived from the plethysmography waveform used for SpO₂ monitoring. Philips has developed enhancements to its FAST Pulse Oximetry technology to derive respiratory rate from plethysmography (Respiration from Pleth, RfP). This clinical investigation is designed to validate the accuracy and performance of the RfP algorithm by comparing pleth-derived respiratory rate with respiratory rate obtained from clinician-annotated capnography waveforms.
This is a multi-center, prospective, non-randomized, non-blinded observational study enrolling adult and pediatric inpatients who are spontaneously breathing room air and undergoing routine spot-check vital signs. Each participant completes one study visit. Age- and weight-appropriate Philips SpO₂ sensors (finger, nasal alar, ear) are placed according to the sensor Instructions for Use, and capnography is collected using the LoFlo Sidestream etCO₂ sensor with adult or pediatric oral/nasal cannulas. For each applicable sensor type, a 20-minute plethysmography and capnography recording is collected. A spot-check analysis window covering the first 5 minutes of the finger-sensor recording is also evaluated. Manual respiratory rate is recorded once during this period.
Waveform data are annotated by clinicians blinded to other signals to identify normal breathing, exclude artifacts, and determine reference respiratory rate values. Respiratory rate accuracy is evaluated using Accuracy Root Mean Square (ARMS), mean bias, and precision. Predefined performance criteria specify ARMS ≤ 3 breaths per minute and mean bias between -1 and +1 BPM for each population. The investigation also evaluates time to first valid pleth-derived respiratory-rate value, as well as adult participant acceptability of the CO₂ cannula. Data collected during the study do not influence patient care, and the investigational respiratory-rate algorithm is not displayed on the monitoring equipment during data acquisition.
- Conditions
- Respiratory Rate Monitoring
- Being tested
- Physiological Monitoring with SpO₂ Sensors and Capnography
- Keywords
- Respiration rate, Capnography, Plethysmography, RfP Algorithm, Respiration from plethysmography, Device performance validation, Pulse oximetry, Vital signs monitoring, FAST Pulse Oximetry technology, SpO₂ sensors, Pleth-derived respiratory rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological Monitoring with SpO₂ Sensors and CapnographyDevice
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Adult Inpatients | Adult participants (aged 18 years and older) will undergo noninvasive physiological monitoring using adult-appropriate Philips SpO₂ sensors during a single study visit. Each participant completes two separate 20-minute recording cycles. The first cycle includes simultaneous monitoring with the M1191T adult finger sensor (>50 kg) and the nasal alar sensor (989803205391; ≥15 kg). The second cycle includes the M1191T adult finger sensor and the M1194A ear sensor (>40 kg). During both cycles, capnography is recorded concurrently using the LoFlo Sidestream etCO₂ sensor (M2741A) connected to an adult oral/nasal cannula (989803206671). All monitoring is observational, and device outputs are not used for clinical decision-making. Receives: Device: Physiological Monitoring with SpO₂ Sensors and Capnography | |
| Pediatric Inpatients | Pediatric participants aged 4-17 years receiving physiological monitoring with pediatric-appropriate Philips SpO₂ sensors (M1192A finger glove for 15-50 kg; nasal alar sensors for ≥15 kg; ear sensor M1194A for >40 kg when age ≥12 years). Participants complete one or two 20-minute recording cycles depending on age/weight per protocol. Capnography is collected using the LoFlo Sidestream etCO₂ sensor with pediatric oral/nasal cannula (989803206681). Receives: Device: Physiological Monitoring with SpO₂ Sensors and Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During the 20-minute continuous monitoring period for the finger sensor.
Secondary outcomes (8)
Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)
ARMS comparing pleth-derived RR with annotated capnography for alar, ear, and pooled sensors.
Measured: 20-minute continuous monitoring period.
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.
Measured: 20-minute continuous monitoring.
Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)
Standard deviation of pleth-derived RR error relative to capnography.
Measured: 20-minute continuous monitoring.
Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)
ARMS during the first 5 minutes ("spot-check window") compared with capnography.
Measured: 0-5 minutes after sensor connection (spot-check period).
Mean Bias - Finger Sensor (Spot-Check Monitoring)
Mean difference (pleth RR - capnography RR) for finger sensor during spot-check.
Measured: 0-5 minutes after sensor connection (spot-check period).
Precision - Finger Sensor (Spot-Check Monitoring)
Standard deviation of pleth-derived RR error during spot-check.
Measured: 0-5 minutes after sensor connection (spot-check period).
Time to First Valid Pleth-Derived Respiratory Rate Value
Number of seconds from "Start Time Product View" (first waveform perturbation after sensor connection) to first valid pleth-derived RR value that meets data quality criteria.
Measured: Measured during the initial minutes of recording for each finger-sensor cycle.
Patient Acceptability and Satisfaction (Adult CO₂ Cannula Survey)
Likert-scale survey evaluating adult participant comfort, fit, and satisfaction with the CO₂ cannula.
Measured: Immediately after monitoring procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start6 Feb 2026
- Primary completion25 May 2026 (estimated)
- Study completion25 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Rate MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449715
- Sponsor's protocol ID
- CC-301246-RfP Validation Study
- Other IDs
- IRAS Project ID: 363841
- Acronym
- RfP Validation
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Privacy concerns
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiration From Pleth Validation
- ClinicalTrials.gov ID
- NCT07449715
- Acronym / sponsor ID
- RfP Validation / CC-301246-RfP Validation Study
- Conditions
- Respiratory Rate Monitoring
- Keywords
- Respiration rate, Capnography, Plethysmography, RfP Algorithm, Respiration from plethysmography, Device performance validation, Pulse oximetry, Vital signs monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 25 May 2026 (estimated)
- Study completion
- 25 May 2026 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Respiratory rate is a key clinical vital sign and an early indicator of patient deterioration, but traditional manual counting is often inaccurate and inconsistently performed. Prior research has demonstrated that respiratory rate can be derived from the plethysmography waveform used for SpO₂ monitoring. Philips has developed enhancements to its FAST Pulse Oximetry technology to derive respiratory rate from plethysmography (Respiration from Pleth, RfP). This clinical investigation is designed to validate the accuracy and performance of the RfP algorithm by comparing pleth-derived respiratory rate with respiratory rate obtained from clinician-annotated capnography waveforms.
This is a multi-center, prospective, non-randomized, non-blinded observational study enrolling adult and pediatric inpatients who are spontaneously breathing room air and undergoing routine spot-check vital signs. Each participant completes one study visit. Age- and weight-appropriate Philips SpO₂ sensors (finger, nasal alar, ear) are placed according to the sensor Instructions for Use, and capnography is collected using the LoFlo Sidestream etCO₂ sensor with adult or pediatric oral/nasal cannulas. For each applicable sensor type, a 20-minute plethysmography and capnography recording is collected. A spot-check analysis window covering the first 5 minutes of the finger-sensor recording is also evaluated. Manual respiratory rate is recorded once during this period.
Waveform data are annotated by clinicians blinded to other signals to identify normal breathing, exclude artifacts, and determine reference respiratory rate values. Respiratory rate accuracy is evaluated using Accuracy Root Mean Square (ARMS), mean bias, and precision. Predefined performance criteria specify ARMS ≤ 3 breaths per minute and mean bias between -1 and +1 BPM for each population. The investigation also evaluates time to first valid pleth-derived respiratory-rate value, as well as adult participant acceptability of the CO₂ cannula. Data collected during the study do not influence patient care, and the investigational respiratory-rate algorithm is not displayed on the monitoring equipment during data acquisition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Inpatients | – | Device: Physiological Monitoring with SpO₂ Sensors and CapnographyAdult participants (aged 18 years and older) will undergo noninvasive physiological monitoring using adult-appropriate Philips SpO₂ sensors during a single study visit. Each participant completes two separate 20-minute recording cycles. The first cycle includes simultaneous monitoring with the M1191T adult finger sensor (>50 kg) and the nasal alar sensor (989803205391; ≥15 kg). The second cycle includes the M1191T adult finger sensor and the M1194A ear sensor (>40 kg). During both cycles, capnography is recorded concurrently using the LoFlo Sidestream etCO₂ sensor (M2741A) connected to an adult oral/nasal cannula (989803206671). All monitoring is observational, and device outputs are not used for clinical decision-making. |
| Pediatric Inpatients | – | Device: Physiological Monitoring with SpO₂ Sensors and CapnographyPediatric participants aged 4-17 years receiving physiological monitoring with pediatric-appropriate Philips SpO₂ sensors (M1192A finger glove for 15-50 kg; nasal alar sensors for ≥15 kg; ear sensor M1194A for >40 kg when age ≥12 years). Participants complete one or two 20-minute recording cycles depending on age/weight per protocol. Capnography is collected using the LoFlo Sidestream etCO₂ sensor with pediatric oral/nasal cannula (989803206681). |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological Monitoring with SpO₂ Sensors and CapnographyParticipants 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. | Device | Adult Inpatients, Pediatric Inpatients |
Primary outcome
Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring
Time frame: During the 20-minute continuous monitoring period for the finger sensor.
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).
8 secondary outcomes
Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)
Time frame: 20-minute continuous monitoring period.
Mean Bias - All Sensor Types (Continuous Monitoring)
Time frame: 20-minute continuous monitoring.
Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)
Time frame: 20-minute continuous monitoring.
Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)
Time frame: 0-5 minutes after sensor connection (spot-check period).
Mean Bias - Finger Sensor (Spot-Check Monitoring)
Time frame: 0-5 minutes after sensor connection (spot-check period).
Precision - Finger Sensor (Spot-Check Monitoring)
Time frame: 0-5 minutes after sensor connection (spot-check period).
Time to First Valid Pleth-Derived Respiratory Rate Value
Time frame: Measured during the initial minutes of recording for each finger-sensor cycle.
Patient Acceptability and Satisfaction (Adult CO₂ Cannula Survey)
Time frame: Immediately after monitoring procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. Privacy concerns
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Rate Monitoring, run by Philips Clinical & Medical Affairs Global at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nero Evero, Clinical Study Manager, MS (+1 720-201-7689, nero.evero@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring (time frame: During the 20-minute continuous monitoring period for the finger sensor.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.