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Age: 4Years +
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ID07449715

Respiration From Pleth Validation of Respiratory Rate Using Philips FAST Pulse Oximetry Technology in Adult and Pediatric Inpatients

Led by Philips Clinical & Medical Affairs Global · Updated on 2026-03-04

113

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the accuracy and performance of a new method to measure respiratory rate derived from the plethysmography waveform using Philips FAST Pulse Oximetry technology. This observational study includes adult and pediatric inpatients who are breathing room air and undergoing routine spot-check vital sign monitoring. The goal is to compare respiratory rates obtained from this new noninvasive method with those measured by capnography, a reference standard, to see how well the new algorithm performs without affecting patient care. Participants will undergo noninvasive physiological monitoring during a single study visit using age- and weight-appropriate Philips SpO2 sensors finger, nasal alar, ear along with capnography sensors. Adults will complete two separate 20-minute recording cycles with different sensor combinations, while pediatric participants will complete one or two 20-minute cycles depending on age and weight. Capnography data will be collected simultaneously to serve as the reference for respiratory rate. During the study visit, waveform data will be annotated by clinicians to identify normal breathing and exclude artifacts. Researchers will measure respiratory rate accuracy using metrics such as Accuracy Root Mean Square ARMS, mean bias, and precision during continuous and spot-check monitoring. They will also assess the time to first valid respiratory rate value and adult participant satisfaction with the CO2 cannula. All data collection occurs in a single visit, and no device outputs will be used for clinical decisions.

CONDITIONS

Brief Title

Respiration From Pleth Validation

Who Can Participate

Age: 4Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult participants aged 18 years or older able to provide written informed consent
  • Pediatric participants aged 4 to 17 years with parent or guardian able to provide consent and assent as applicable
  • Participant weight suitable for at least one Philips SpO2 sensor under test
  • Willing and able to wear study devices for the entire study procedures
  • Undergoing regular spot-check vital sign measurements as per standard care
Not Eligible

You will not qualify if you...

  • Patients receiving palliative care
  • Patients with tremors, cardiac pacemakers, or known atrial fibrillation
  • Patients receiving oxygen supplementation during study participation
  • Critically ill patients with severe physiological instability
  • Pregnant or lactating patients (self-reported)
  • Injury, wounds, or physical malformations at sensor application sites
  • Severe contact allergies to adhesives, latex, or materials in pulse oximetry sensors
  • Unwilling or unable to remove colored nail polish or artificial nails from application sites
  • Unwilling or unable to remove foreign objects such as nose or ear jewelry from sensor sites
  • Nail fungus on sensor application sites
  • Severe dermatitis or hyperkeratosis at sensor application sites

Research Team

N

Nero Evero, Clinical Study Manager, MS

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