Monitoring vital signs in hospitalized patients using advanced sensors
Data Collection Study for RFP (Respiration From Plethysmogram)
NA · Philips Clinical & Medical Affairs Global · NCT06633861
This study is testing new sensors to see if they can better monitor oxygen and carbon dioxide levels in hospitalized patients, including both adults and kids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 4 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global (industry) |
| Locations | 1 site (Wales, Bangor) |
| Trial ID | NCT06633861 on ClinicalTrials.gov |
What this trial studies
This study involves hospitalized patients who will undergo routine spot-check monitoring of vital signs. It aims to measure oxygen saturation using various Philips SpO2 finger sensors while simultaneously monitoring CO2 levels with a nasal cannula. The collected data will help improve algorithms for respiratory rate measurement using the saturation probe and Philips FAST pulse oximeter system. The study will include a total of 75 participants, comprising both adults and pediatric patients.
Who should consider this trial
Good fit: Ideal candidates include hospitalized adults and pediatric patients aged 4 years and older who are undergoing regular spot-check measurements.
Not a fit: Patients who are critically ill, palliative, or have severe physical conditions affecting sensor application will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of vital sign monitoring, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in improving vital sign monitoring techniques, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wales, Bangor
- Ysbyty Gwynedd Hospital — Wales, Bangor, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Christian P Subbe, Dr. — Betsi Cadwaladr University Local Health Board
- Study coordinator: Elke Naujokat, Dr.
- Email: elke.naujokat@philips.com
- Phone: +49 151 28906472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: In-patients Assessment of Vital Signs, vital signs