Validation of respiratory rate measurement from the plethysmography waveform

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational project enrolls adult and pediatric inpatients who are spontaneously breathing and undergoing routine spot-check vital signs. Age- and weight-appropriate Philips SpO2 sensors (finger, nasal alar, ear) are placed while capnography (sidestream etCO2 with oral/nasal cannula) is recorded as the reference standard; 20-minute plethysmography and capnography recordings are collected per applicable sensor with a 5-minute spot-check window on the finger sensor. Manual respiratory rate is recorded once, waveform data are clinician-annotated, and algorithm outputs are not used for clinical care. The pleth-derived respiratory rate from the Philips RfP algorithm is compared to capnography to determine accuracy, mean bias, precision, and time to first valid respiratory-rate value.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Hospital
  Durham, North Carolina, United States Recruiting
• Ysbyty Gwynedd
  Bangor, Gwynedd, United Kingdom Not yet recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.