The vital signs are critical in assessing the severity and prognosis of infections, such as Covid-19. 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). This project aims to evaluate a new camera-based system for contactless measurement of vital signs as well as an artificial intelligence (AI) predicting hospitalization or death within 30 days. This particular study will evaluate the new system's ability without interfering with standard care of the patient.
Background and aim:
The vital signs are critical in assessing the severity and prognosis of infections, i.e.,
Covid-19, influenza, sepsis and pneumonia. Quick and accurate triage is critical when facing
a pandemic with an overwhelming number of cases (confirmed and suspected). This study aims a)
to evaluate a new method for rapid camera-based non-contact measurement of five vital signs;
body temperature, heart rate, blood oxygen saturation, respiratory rate, and blood pressure,
and b) if an AI can predict hospitalization or death within 30 days.
Methods:
A method-comparison study design is used comparing each vital sign measured with the new
method to the corresponding standard reference method. Furthermore, a cohort design is used
to follow up any hospitalization or death within 30 days. The investigated new system
consists of a high-speed digital video camera, a digital radiometric infrared camera, LED
lights and a computer for data recording. This system faces the subject at a distance of
approximately one meter, capturing a 30 second recording of the subject's face. First, all
vital signs will be measured using one set of reference devices. Secondly the investigated
device will record a 30 second video of the patient's face. Thirdly, and last, all vital
signs will be measured using the same set of reference devices. A copy of the vital sign
readings (using the standard reference methods) will be handed over by an investigator to the
clinical professionals responsible for the subsequent medical care for each subject.
Afterwards, the collected 30-second recordings will be run through specific software
algorithms to extract the vital signs. The results from the new camera-based contactless
measurement of vital signs and the outcome of the AIs prediction of risk for hospitalization
or death will not be presented in the care situation of the patient.
Expected Findings:
It is expected that the proposed study will show that the new method can estimate body
temperature, heart rate, respiratory rate, blood oxygen level, and blood pressure with an
acceptable agreement compared with the reference method and also estimate hospitalization or
death within 30 days.
Implications of the expected findings:
Being able to measure vital signs quicker than before by using a new contactless method would
greatly facilitate triage of large number of patients. Also being able to predict
hospitalization or increased risk for death would further improve the triage of patients.
Device: RIA-device (Remote Investigation and Assessment)
The investigated new system consists of a high-speed digital video camera, a digital radiometric infrared camera, LED lights and a computer for data recording. This system faces the subject at a distance of approximately one meter, capturing a 30 second recording of the subject's face.
Inclusion Criteria:
1. The patient is attending for triage presenting with symptoms of an infection.
2. Subject has provided informed consent
3. Age ≥18 years
4. Fluent in Swedish (reading, writing, conversational)
5. Mental state is such that he or she is able to understand and give informed consent to
participation in the study by signing the Information and Consent Form
6. The investigator determines that the new method, and the reference methods, can be
used as intended with adequate reliability and safety
7. The time for investigations in this study is estimated to approximately 15-20 minutes.
Vital signs will be handed over to the care provider responsible for the further
management of the patient saving approximately 5-10 minutes of their time. Hence, the
delay in the management of each patient introduced by this study is approximately 10
minutes. Patients deemed being in such a severe medical condition on arrival, that 10
minutes of delay is deemed detrimental will not be included.
Exclusion Criteria:
1. Depressed level of consciousness from inclusion up until all investigations are
completed (during approximately 15-20 minutes).
2. Patient request to be withdrawn from the study.
Östra Sjukhuset
Gothenburg, Sweden
Ronny K Gunnarsson, MD PhD, Principal Investigator
Primary Health care, Regionhalsan, Region Vastra Gotaland, Sweden