Recruiting

Observational Study

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT07449715

Conditions

Respiratory Rate Monitoring

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

Interventions

Physiological Monitoring with SpO₂ Sensors and Capnography

Study Details

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

Study ID

NCT07449715

Start date

Feb 6, 2026

Status verified date

Feb, 2026

Completion date

May 25, 2026

Anticipated

Primary completion date

May 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Not accepted

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 Design

Enrollment

113 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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).

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nero Evero, Clinical Study Manager, MS

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

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

David MacLeod, Associate Professor of Anesthesiology, MBBS

919-681-6437david.macleod@duke.edu

Principal Investigator:

David MacLeod, MBBS

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-03-04.