Remote Investigation and Assessment of Vital Signs (RIA-VS)

September 16, 2025 updated by: Vastra Gotaland Region

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
860

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Ulricehamn, Sweden, 52337
        • Recruiting
        • Hälsobrunnen Vårdcentral
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

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:

  1. The patient is attending primary or secondary health care.
  2. The subject has provided informed consent.
  3. Age ≥18 years.
  4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
  5. The patient is willing and able to give informed consent ".
  6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
  7. 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:

  1. Patients attending primary health care.
  2. The subject has provided informed consent.
  3. Age ≥18 years.
  4. Fluent in Swedish, English, Somali or Arabic (we will translate the patient information and ensure an interpreter can be present for translating questions).
  5. The patient is willing and able to give informed consent .
  6. The investigator determines that the new study device, and the reference methods, can be used as intended with adequate safety.
  7. 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.

Exclusion Criteria:

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.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants
All participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS)
Diagnostic test: RIA-VS
Measuring vital signs with a new contactless camera technique
Other Names:
  • Remote Investigation and Assessment of Vital Signs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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:

  1. 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.
  2. 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.
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

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.
The time delay between the measurements using conventional techniques and the new RIA-VS device will be approximately 5 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Göteborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronny Gunnarsson, MD PhD, School of Public Health and Community Medicine, Gothengurg University, Sweden

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1261-8273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A deidentified raw data file will be publicly available.

IPD Sharing Time Frame

Raw data will be made available upon acceptance of final manuscript for publication

IPD Sharing Access Criteria

Publicly available to anyone

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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