Respiration From Pleth Validation
Philips Clinical & Medical Affairs Global
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.
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 r…
Eligibility
- Age range
- 4+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
Interventions
- DevicePhysiological 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.
Locations (2)
- Duke University HospitalDurham, North Carolina
- Ysbyty GwyneddBangor, Gwynedd