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Completed

NCT Number: NCT06633861

Data Collection Study for RFP (Respiration From Plethysmogram)

The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ysbyty Gwynedd Hospital

Wales, Bangor, United Kingdom

About this study

In an additional spot-check measurement procedure, the study will measure oxygen saturations through different Philips SpO2 finger sensors. Patients will wear a nasal cannula linked to a CO2 measuring device at the same time. The data from both devices will be used to design and improve algorithms for measurement of respiratory rate with the saturation probe and the Philips FAST pulse oximeter system. The study will include 50 adult patients and 25 pediatric patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (aged 18 years or older) willing and able to understand and provide written informed consent
  • Paediatric subjects aged 16 years and older willing and able to understand and provide written informed consent
  • Paediatric subjects aged approx. 4-16 years and their legal guardians, willing and able to understand and provide written informed consent/assent
  • Subject weight within intended use of at least one SpO2 sensor under test at time of enrolment (M1191T: adult patients >50kg, M1196T: adult patients >40kg, M1192A: paediatric patients 15-50kg)
  • Willing and able to wear study devices during study procedures
  • Subject undergoing regular spot-check measurements as per the site's standard of care

Exclusion criteria

  • Palliative patients
  • Critically ill patients with severe physiological instability (NEWS ≥9)
  • Injury/wounds or physical malformation of sensor application site (i.e. fingers, toes, hands, feet)
  • Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors (self-reported)
  • Unwillingness or inability to remove coloured nail polish or artificial nails from application site
  • Nail fungus on application site
  • Severe dermatitis or hyperkeratosis (e.g. ichthyosis) at sensor application site

Treatment and study plan

spot-check measurement

Device

Spot-check measurement: different Philips SpO2 sensors and Philips FAST pulse oximeter system, capnography

Primary outcomes

  1. Data collection for database for algorithm development

    Time frame: 6 months

    Anonymized database of subject data from the Oxygen Saturation finger sensors (photoplethysmogram waveform) and the reference sensors (capnography waveform)

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Collaborators

  • Betsi Cadwaladr University Health Board

Registry information

Acronym: SAT+

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.