Validation of respiratory rate measurement from the plethysmography waveform
Respiration From Pleth Validation
This test tries to see if Philips' algorithm can accurately measure breathing rate from pulse oximeter waveforms in hospitalized adults and children.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 113 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT07449715 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult and pediatric inpatients who are breathing on their own, fall within the sensors' weight ranges, and can wear the SpO2 and capnography sensors during a single hospital visit.
Not a fit: Patients who are mechanically ventilated or not breathing spontaneously, those outside the device weight ranges, or those unable to tolerate the sensors are unlikely to benefit from this validation.
Why it matters
Potential benefit: If successful, the RfP algorithm could give accurate, noninvasive respiratory rate readings from standard SpO2 sensors and enable more continuous monitoring without extra equipment.
How similar studies have performed: Prior research has shown plethysmography-derived respiratory rate is feasible and small validation studies reported promising accuracy, but broader commercial algorithm validation remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Durham, North Carolina and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.