Respiration From Pleth Validation (RfP Validation)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Rate Monitoring
• Intervention / Treatment: Device: Physiological Monitoring with SpO₂ Sensors and Capnography

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 Type: Observational
• Enrollment (Estimated): 113

Contacts and Locations

• Study Contact: Name: Nero Evero, Clinical Study Manager, MS; Phone Number: +1 720-201-7689; Email: nero.evero@philips.com

Study Locations

• United Kingdom
  • Gwynedd
    • Bangor, Gwynedd, United Kingdom, LL57 2PW
      • Not yet recruiting
      • Ysbyty Gwynedd
      • Contact: Manohar Joishy, Clinical Director, Paediatrics, MD; Phone Number: +44 03000 841 295; Email: manohar.joishy@wales.nhs.uk
      • Principal Investigator: Manohar Joishy, MD
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Hospital
      • Contact: David MacLeod, Associate Professor of Anesthesiology, MBBS; Phone Number: 919-681-6437; Email: david.macleod@duke.edu
      • Principal Investigator: David MacLeod, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Adult Participants (defined as aged 18 years or older): Willing and able to understand and provide written informed consent

2. 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
3. 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

4. Participant weight is within intended use of at least one SpO2 sensor under test as time of enrollment.

   • 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
5. Willing and able to wear study devices for the entirety of study procedures
6. Undergoing regular spot-check measurements as per the site's standard of care

Exclusion Criteria:

1. Palliative patients
2. Patients with tremors, cardiac pacemakers, or known atrial fibrillation
3. Patients receiving oxygen supplementation at the time of study participation
4. Critically ill patients with severe physiological instability
5. Pregnant and/or lactating patients (self-reported)
6. Injury, wounds, and/or physical malformation of any sensor application site (e.g., fingers, nose, ear)
7. Self-reported severe contact allergies to standard adhesives, latex, and/or other materials found in pulse oximetry sensors
8. Unwillingness or inability to remove colored nail polish or artificial nails from the application site
9. Unwillingness or inability to remove foreign objects, such as nose and/or ear jewelry from sensor application sites
10. Nail fungus on application site
11. Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Physiological Monitoring with SpO₂ Sensors and Capnography; 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.
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).	Device: Physiological Monitoring with SpO₂ Sensors and Capnography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During the 20-minute continuous monitoring period for the finger sensor.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)	ARMS comparing pleth-derived RR with annotated capnography for alar, ear, and pooled sensors.	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.	20-minute continuous monitoring.
Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)	Standard deviation of pleth-derived RR error relative to capnography.	20-minute continuous monitoring.
Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)	ARMS during the first 5 minutes ("spot-check window") compared with capnography.	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.	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.	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 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.	Immediately after monitoring procedure.

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Plethysmography; Pulse oximetry; Capnography; Respiration rate; Vital signs monitoring; RfP Algorithm; Respiration from plethysmography; Device performance validation; FAST Pulse Oximetry technology; SpO₂ sensors; Pleth-derived respiratory rate
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Respiratory Function Tests; Monitoring, Physiologic; Capnography
• Other Study ID Numbers: CC-301246-RfP Validation Study; IRAS Project ID: 363841 (Other Identifier: Health Research Authority in the UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Privacy concerns

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No