Respiration From Pleth Validation

NCT07449715 | Recruiting FDA Device

• 2 other identifiers: CC-301246-RfP Validation StudyIRAS Project ID: 363841
• Study Type: observational
• Target: 113
• Locations: 2 countries
• Sites: 2

Brief 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 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.

Conditions

Respiratory Rate Monitoring

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

Outcome Measures

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).

  During the 20-minute continuous monitoring period for the finger sensor.

Secondary Outcomes (8)

• Accuracy (ARMS) - Nasal Alar, Ear, and Pooled Sensors (Continuous Monitoring)

  20-minute continuous monitoring period.

• Mean Bias - All Sensor Types (Continuous Monitoring)

  20-minute continuous monitoring.

• Precision (Standard Deviation) - All Sensor Types (Continuous Monitoring)

  20-minute continuous monitoring.

• Accuracy (ARMS) - Finger Sensor (Spot-Check Monitoring)

  0-5 minutes after sensor connection (spot-check period).

• Mean Bias - Finger Sensor (Spot-Check Monitoring)

  0-5 minutes after sensor connection (spot-check period).

Study Arms (2)

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

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

Interventions

Physiological Monitoring with SpO₂ Sensors and Capnography DEVICE

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.

Adult Inpatients; Pediatric Inpatients

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (2)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

Ysbyty Gwynedd

Bangor, Gwynedd, LL57 2PW, United Kingdom

NOT YET RECRUITING

MeSH Terms

Interventions

Monitoring, Physiologic; Capnography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Central Study Contacts

Nero Evero, Clinical Study Manager, MS

CONTACT

+1 720-201-7689; nero.evero@philips.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: February 6, 2026
• Primary Completion: May 25, 2026
• Study Completion: May 25, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); GB (1)