Remote Investigation and Assessment of Vital Signs

NCT05022264 | Recruiting

• 1 other identifier: U1111-1261-8273
• Study Type: observational
• Target: 860
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Pressure; Pulse Rate; Respiratory Rate; Oxygen Saturation; Body Temperature

Outcome Measures

Primary Outcomes (1)

• 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: 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 Outcomes (2)

• Estimate test-retest reliability of 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

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

Study Arms (1)

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

Interventions

RIA-VS DIAGNOSTIC_TEST

Measuring vital signs with a new contactless camera technique

Also known as: Remote Investigation and Assessment of Vital Signs

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).
• 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 .

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (1)

Hälsobrunnen Vårdcentral

Ulricehamn, 52337, Sweden

RECRUITING

Study Officials

• Ronny Gunnarsson, MD PhD

  School of Public Health and Community Medicine, Gothengurg University, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronny Gunnarsson, MD PhD

CONTACT

+46 31 786 6835; ronny.gunnarsson@gu.se

Carl Wikberg, PhD

CONTACT

+46 703821660; carl.wikberg@allmed.gu.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 26, 2021
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Raw data will be made available upon acceptance of final manuscript for publication
• Access Criteria: Publicly available to anyone

Locations

SE (1)