RFP Validation Study
Research type
Research Study
Full title
Respiration from Pleth Validation (Deriving the Respiratory rate from Oxygen Saturation Plethysmography: a validation study for use in adults and children)
IRAS ID
363841
Contact name
Manohar Joishy
Contact email
Sponsor organisation
Philips Medizin Systeme Boeblingen GmbH
Duration of Study in the UK
0 years, 4 months, 23 days
Research summary
Respiratory rate is a clinically important parameter that provides information of a patient’s degree of physiological stability. A change in respiratory status is an indicator that may precede serious conditions including sepsis, catastrophic bleeding, any cause of shock, respiratory tract infection, respiratory depression, and respiratory failure. In clinical practice recording of respiratory rate is often unreliable. This can be due to inaccuracy of manual counting and low compliance by clinical staff. The current standard of care technique for monitoring respiratory rate is manual observation, counting the number of breaths taken in one minute.
Research has shown it is possible to derive the respiratory rate from the plethysmography waveform, the waveform used to derive oxygen saturations (SpO2), and the technology has been made available in competitor products. Respiratory rate derivation from pleth (RFP) should be incorporated into the Philips product due to clinical need, advancement of competitor products, regulatory demands, and customer requirements. The addition of respiratory rate monitoring from SpO2 streamlines monitoring of both oxygenation and respiration status within one sensor.
Therefore, the purpose of this clinical investigation is to validate the respiratory rate derived by the Philips RfP algorithm compared to ground truth respiratory rate derived from capnography waveform annotated by clinicians.
This will be accomplished by enrolling at least 78 adult and 35 paediatric research participants, across two investigation sites. Enrolled participants who have provided proper informed consent/assent and are eligible for the study, will undergo study procedures including this Monk Skin Tone assessment, SpO2 and capnography measurement procedures (~65 minutes for adults and ~35 minutes for paediatric patients), adverse event and device deficiency monitoring over the course of a single study visit.
REC name
Wales REC 6
REC reference
25/WA/0333
Date of REC Opinion
19 Dec 2025
REC opinion
Further Information Favourable Opinion