Data Collection Study for RFP (Respiration From Plethysmogram) (SAT+)

September 9, 2025 updated by: Philips Clinical & Medical Affairs Global
The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bangor
      • Wales, Bangor, United Kingdom
        • Ysbyty Gwynedd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In-patients with routine spot-check monitoring of vital signs
Device: spot-check measurement
Spot-check measurement: different Philips SpO2 sensors and Philips FAST pulse oximeter system, capnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Collaborators

Betsi Cadwaladr University Health Board

Investigators

  • Principal Investigator: Christian P Subbe, Dr., Betsi Cadwaladr University Local Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Actual)

November 7, 2024

Study Completion (Actual)

November 7, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200088 (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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