Actively Recruiting

Age: 18Years +
All Genders
ID05022264

Remote Investigation and Assessment of Vital Signs

Led by Vastra Gotaland Region · Updated on 2025-09-22

860

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

V

Vastra Gotaland Region

Lead Sponsor

G

Göteborg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new camera-based system called RIA-VS for measuring vital signs without physical contact. This study aims to reduce the risk of infection transfer that can occur with traditional contact-based devices while accurately capturing important signs like pulse, blood pressure, respiratory rate, oxygen saturation, and body temperature. The project includes a focus on device validity and reliability across different patient groups, including those with various skin types. The study includes three parts: one assessing the device's accuracy in measuring body temperature, another evaluating all vital signs except body temperature, and a third examining differences in device performance among people with different skin tones. Participants will have their vital signs measured both with conventional methods and the new camera-based device, called RIA-VS. Measurements are taken with about a 5-minute delay between methods to compare results. Participants aged 18 years and older attending primary or secondary healthcare will be involved. They will provide informed consent and have vital signs measured using both standard techniques and the RIA-VS device. The study will measure agreement between conventional methods and the new device, test-retest reliability, and the influence of skin type on measurement accuracy. The safety and timing impact on patient care are also monitored, with study procedures designed not to delay treatment by more than 15-20 minutes.

CONDITIONS

Brief Title

Remote Investigation and Assessment of Vital Signs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient is attending primary or secondary health care.
  • The subject has provided informed consent.
  • Age 18 years or older.
  • Fluent in Swedish, English, Somali, or Arabic.
  • The patient is willing and able to give informed consent.
  • The investigator determines the new study device and reference methods can be used safely.
  • The delay in patient management introduced by the study is approximately 15-20 minutes and is not harmful to the patient.
Not Eligible

You will not qualify if you...

  • Subjects may be withdrawn due to unexpected depressed level of consciousness anytime during the study period of about 15-20 minutes.
  • Any reduction in consciousness after inclusion will lead to withdrawal from the study.
  • Patients in such severe medical condition that a 15-20 minute delay is detrimental will not be included.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 15 to 20 minutes

Participants have their vital signs measured with conventional techniques and the new experimental medical device (RIA-VS) using a contactless camera technique.

1 visit (in-person)

Long-term Monitoring

Duration - Up to the end of the study follow-up period

Participants may be observed for test-retest reliability and influence of different skin types on the validity of the new device.

Additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 1 location

1

Hälsobrunnen Vårdcentral

Ulricehamn, Sweden, 52337

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Research Team

R

Ronny Gunnarsson, MD PhD

C

Carl Wikberg, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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