Remote Investigation and Assessment of Vital Signs

NCT ID: NCT05022264

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 860 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2027-06-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants

All participants will have their vital signs measured with conventional techniques as well as with the new experimental medical device (labelled RIA-VS)

RIA-VS

Intervention Type: DIAGNOSTIC_TEST

Measuring vital signs with a new contactless camera technique

Interventions

RIA-VS

Measuring vital signs with a new contactless camera technique

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Remote Investigation and Assessment of Vital Signs

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronny Gunnarsson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hälsobrunnen Vårdcentral

Ulricehamn, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Ronny Gunnarsson, MD PhD

Role: CONTACT

ronny.gunnarsson@gu.se

+46 31 786 6835

Carl Wikberg, PhD

Role: CONTACT

carl.wikberg@allmed.gu.se

+46 703821660

Facility Contacts

Adam Einstein, MD

Role: primary

adam.einstein@ptj.se

+46731519301

Other Identifiers

U1111-1261-8273

Identifier Type: -

Identifier Source: org_study_id