Respiration From Pleth Validation

Overview

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.

Interventions

• 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

Primary outcome measures

• Respiratory Rate Accuracy (ARMS) - Finger Sensors, Continuous Monitoring [Time frame: During the 20-minute continuous monitoring period for the finger sensor.]

Secondary outcome measures (8)

• 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.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Duke University Hospital — Durham

United Kingdom · 1 center

• Ysbyty Gwynedd — Bangor

Identifiers

NCT: NCT07449715 · CC-301246-RfP Validation Study · IRAS Project ID: 363841

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗