Remote Investigation and Assessment of Vital Signs

Last updated: September 16, 2025
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

RIA-VS

Clinical Study ID

NCT05022264
U1111-1261-8273
  • Ages > 18
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

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 patientinformation 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 isapproximately 15-20 minutes. Patients deemed being in such a severe medicalcondition 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 patientinformation 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 isapproximately 15-20 minutes. Patients deemed being in such a severe medicalcondition that 15-20 minutes of delay is deemed detrimental will not be included.

Exclusion

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 Design

Total Participants: 860
Treatment Group(s): 1
Primary Treatment: RIA-VS
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Hälsobrunnen Vårdcentral

    Ulricehamn, 52337
    Sweden

    Site Not Available

  • Hälsobrunnen Vårdcentral

    Ulricehamn 2666493, 52337
    Sweden

    Active - Recruiting

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