Blood PressureRIA-VSNCT05022264
Remote Investigation and Assessment of Vital Signs
An observational study of Blood Pressure and Pulse Rate, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Pulse Rate, Respiratory Rate
- What is being tested?
- RIA-VS
- How many people
- 860 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2022to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be consecutive patients attending one of the clinics participating in the study. They will be asked for participation irrespective f reason for attending the clinic. Hence, this study does not focus on any specific medical condition. Participating clinics are one one hospital department for infectious diseases and four clinics for family medicine (general practice / primary health care centers)
Who may be able to join
- The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP2.
- WP1+WP2:
- The patient is attending primary or secondary health care.
- The subject has provided informed consent.
- Age ≥18 years.
- Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
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- The patient is willing and able to give informed consent ".
- The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
- The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.
- WP3:
- Patients attending primary health care.
- The subject has provided informed consent.
- Age ≥18 years.
- Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
- The patient is willing and able to give informed consent .
- The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
- The delay in the management of each patient introduced by this study is approximately 15-20 minutes. Patients deemed being in such a severe medical condition that 15-20 minutes of delay is deemed detrimental will not be included.
Who cannot join
- Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Hälsobrunnen Vårdcentral
Ulricehamn, 52337
Adam Einstein, MD, +46731519301, adam.einstein@ptj.se
About this study
The vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure.
This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
Read the detailed description
STUDY DESIGN:
A method comparison design with three work packages (WP):
WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.
WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).
WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.
STUDY POPULATION:
WP1: Patients aged ≥18 years admitted to or attending a hospital clinic. WP2: Patients aged ≥18 year attending primary health care or patients being admitted to a hospital clinic.
WP3: Individuals aged ≥18 years attending primary health care.
- Being tested
- RIA-VS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIA-VSDiagnostic test
Also called Remote Investigation and Assessment of Vital Signs
Measuring vital signs with a new contactless camera technique
| Study group | Role | What they receive |
|---|---|---|
| Participants | All participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS) Receives: Diagnostic Test: RIA-VS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between conventional techniques and the new RIA-VS device
Estimate the agreement between vital signs estimated with the new RIA-VS study device and vital signs estimated using traditional techniques (the criterion validity). Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure:
- Validity of the new method: The gold standard will be the mean between the two reference methods. The first measurement of the new RIA-VS device will be the new method compared with the gold standard using a Bland-Altman plot. We will also produce simple scatter plots comparing the gold standard with the new RIA-VS device for illustration.
Measured: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Secondary outcomes (2)
Estimate test-retest reliability of the new RIA-VS device
Estimate the new RIA-VS study device test-retest reliability and to compare this with the test-retest reliability of the reference method. Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure:
- Test-retest reliability of the new RIA-VS method: The difference between the two tests will be plotted on the Y-axis and the mean value of the two estimates of the new RIA-VS device on the x-axis in a modified Bland-Altman plot.
- Comparison of the random variability: The variance of the difference between the two measures using the reference method will be compared with the variance from the difference between the two RIA-VS estimates. This enables comparing the random variability of both the reference method as well as the new RIA-VS device.
Measured: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Evaluate the influence of different skin types on the validity of the new RIA-VS study device
Investigate if different Fitzpatrick skin types influences the validity of the new RIA-VS study device. We will use the definition of skin types as described in: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988;124(6):869-71).
The statistics described in the primary outcome measure and the first secondary outcome measure (test-retest reliability) will be made separately for patients with Fitzpatrick skin color type 0-4 as well as type 5-6 to see if skin color influences readings with the new RIA-VS device.
Measured: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Mar 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Ronny Gunnarsson, MD PhD, Principal investigator, School of Public Health and Community Medicine, Gothengurg University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022264
- Sponsor's protocol ID
- U1111-1261-8273
- Acronym
- RIA-VS
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified raw data file will be publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Investigation and Assessment of Vital Signs
- ClinicalTrials.gov ID
- NCT05022264
- Acronym / sponsor ID
- RIA-VS / U1111-1261-8273
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Aug 2021 (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 vital signs (pulse, systolic and diastolic blood pressure, respiratory rate, oxygen saturation and body temperature) are critical in assessing the severity and prognosis of infections. The devices used today for measuring the vital signs have to be in physical contact with the patients. There is an apparent risk of transferring infections from one patient to the next (or to healthcare professionals). Accurately obtaining vital signs is also important when managing other categories of patients where it may be relevant to obtain some of the vital signs such as pulse and blood pressure.
This project aims to evaluate a new camera-based system for contactless measurement of vital signs.
Detailed description
STUDY DESIGN:
A method comparison design with three work packages (WP):
WP1: Focus on estimating validity and reliability of the new study device to measure body temperature.
WP2: Focus on estimating validity and reliability of the new study device to measure all vital signs except body temperature (pulse, systolic and diastolic blood pressure, respiratory rate and oxygen saturation).
WP3: Focus on estimating if there is any difference in the validity and reliability of the new study device to measure all vital signs (except body temperature) in subjects with Fitzpatrick skin type 5-6 as compared with those of skin type 1-4.
STUDY POPULATION:
WP1: Patients aged ≥18 years admitted to or attending a hospital clinic. WP2: Patients aged ≥18 year attending primary health care or patients being admitted to a hospital clinic.
WP3: Individuals aged ≥18 years attending primary health care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: RIA-VSAll participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be consecutive patients attending one of the clinics participating in the study. They will be asked for participation irrespective f reason for attending the clinic. Hence, this study does not focus on any specific medical condition. Participating clinics are one one hospital department for infectious diseases and four clinics for family medicine (general practice / primary health care centers)
Key inclusion criteria (17 listed)
- The same subject can't be enrolled more than once with the exception that subjects in WP1 may also be recruited to WP2.
- The patient is attending primary or secondary health care.
- The subject has provided informed consent.
- Age ≥18 years.
- Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
Key exclusion criteria (1 listed)
- Subjects are free to withdraw from the study at any point. Subjects will also be withdrawn from the study in case of unexpected depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes). Any reduction in consciousness will incur that the subject is withdrawn.
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 |
|---|---|---|
| RIA-VSAlso: Remote Investigation and Assessment of Vital SignsMeasuring vital signs with a new contactless camera technique | Diagnostic test | Participants |
Primary outcome
Agreement between conventional techniques and the new RIA-VS device
Time frame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Estimate the agreement between vital signs estimated with the new RIA-VS study device and vital signs estimated using traditional techniques (the criterion validity). Vital signs in this context are heart rate (pulse), respiratory rate, oxygen saturation (SpO2), systolic as well as diastolic blood pressure, and body temperature. For each vital sign the following statistics will be calculated to answer the outcome measure: a) Validity of the new method: The gold standard will be the mean between the two reference methods. The first measurement of the new RIA-VS device will be the new method compared with the gold standard using a Bland-Altman plot. We will also produce simple scatter plots comparing the gold standard with the new RIA-VS device for illustration.
2 secondary outcomes
Estimate test-retest reliability of the new RIA-VS device
Time frame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Evaluate the influence of different skin types on the validity of the new RIA-VS study device
Time frame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. A deidentified raw data file will be publicly available.
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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.
Ronny Gunnarsson, MD PhD principal investigator
School of Public Health and Community Medicine, Gothengurg University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Pulse Rate, run by Vastra Gotaland Region at 1 site in Sweden.
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 17 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronny Gunnarsson, MD PhD (+46 31 786 6835, ronny.gunnarsson@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between conventional techniques and the new RIA-VS device (time frame: The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes). 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 22 Sep 2025.