In-patients Assessment of Vital SignsSAT+NCT06633861
Data Collection Study for RFP (Respiration From Plethysmogram)
A study testing spot-check measurement in people with In-patients Assessment of Vital Signs, run by Philips Clinical & Medical Affairs Global at 1 site in United Kingdom.
Trial summary
The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- In-patients Assessment of Vital Signs
- What is being tested?
- spot-check measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2024to 7 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.
Read the 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.
- Conditions
- In-patients Assessment of Vital Signs
- Being tested
- spot-check measurement
- Keywords
- vital signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spot-check measurementDevice
Spot-check measurement: different Philips SpO2 sensors and Philips FAST pulse oximeter system, capnography
| Study group | Role | What they receive |
|---|---|---|
| In-patients with routine spot-check monitoring of vital signs | Experimental | In-patients with routine spot-check monitoring of vital signs Receives: Device: spot-check measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start5 Sep 2024
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-patients Assessment of Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Betsi Cadwaladr University Health Board
- Responsible party
- Sponsor
- Investigators
- Christian P Subbe, Dr., Principal investigator, Betsi Cadwaladr University Local Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633861
- Sponsor's protocol ID
- 200088
- Acronym
- SAT+
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection Study for RFP (Respiration From Plethysmogram)
- ClinicalTrials.gov ID
- NCT06633861
- Acronym / sponsor ID
- SAT+ / 200088
- Conditions
- In-patients Assessment of Vital Signs
- Keywords
- vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Betsi Cadwaladr University Health Board
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted in hospitalised patients who undergo spot-check monitoring of vital signs as part of their routine care.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-patients with routine spot-check monitoring of vital signs | Experimental | Device: spot-check measurementIn-patients with routine spot-check monitoring of vital signs |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spot-check measurementSpot-check measurement: different Philips SpO2 sensors and Philips FAST pulse oximeter system, capnography | Device | In-patients with routine spot-check monitoring of vital signs |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian P Subbe, Dr. principal investigator
Betsi Cadwaladr University Local Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spot-check measurement in people with In-patients Assessment of Vital Signs, run by Philips Clinical & Medical Affairs Global at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection for database for algorithm development (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.