NCT05022264

Remote Investigation and Assessment of Vital Signs

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 860 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RIA-VS	Measuring vital signs with a new contactless camera technique

Timeline

• Start date: 2022-03-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2021-08-26
• Last updated: 2025-09-22

Locations

1 site across 1 country: Sweden