Data Collection Study for RFP (Respiration From Plethysmogram)

NCT06633861 | Completed

• 1 other identifier: 200088
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

In-patients Assessment of Vital Signs

Keywords

vital signs

Outcome Measures

Primary Outcomes (1)

• Data collection for database for algorithm development

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

  6 months

Study Arms (1)

In-patients with routine spot-check monitoring of vital signs

EXPERIMENTAL

In-patients with routine spot-check monitoring of vital signs

Device: spot-check measurement

Interventions

spot-check measurement DEVICE

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

In-patients with routine spot-check monitoring of vital signs

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead
• Betsi Cadwaladr University Health Board: collaborator

Study Sites (1)

Ysbyty Gwynedd Hospital

Wales, Bangor, United Kingdom

Location

Study Officials

• Christian P Subbe, Dr.

  Betsi Cadwaladr University Local Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 9, 2024
• Study Start: September 5, 2024
• Primary Completion: November 7, 2024
• Study Completion: November 7, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)