Clinical trial NCT04383457: Covid-19 Triage Using Camera-based AI
Official title: Covid-19 Triage Using Camera-based AI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infections
Keywords: Vital signs
Pulse
Blood pressure
Respiratory rate
Oxygen saturation
Temperature
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Detectivio AB
First posted: 2020-05-12
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients attending the emergency department at Östra sjukhuset Gothenburg for a suspected infection.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Agreement between the new camera based method and reference standard to estimate body temperature
timeFrame: Two minutes between measurements
measure: Agreement between the new camera based method and reference standard to estimate heart rate
timeFrame: Two minutes between measurements
measure: Agreement between the new camera based method and reference standard to estimate blood oxygen saturation
timeFrame: Two minutes between measurements
measure: Agreement between the new camera based method and reference standard to estimate systolic blood pressure
timeFrame: Two minutes between measurements
measure: Agreement between the new camera based method and reference standard to estimate diastolic blood pressure
timeFrame: Two minutes between measurements
measure: Agreement between the new camera based method and reference standard to estimate respiratory rate
timeFrame: Two minutes between measurements
Secondary outcomes:
measure: Prediction of hospital admission using vital signs estimated using reference standard methods
timeFrame: Hospital admission for any cause up until 30 days after inclusion
measure: Prediction of death using vital signs estimated using reference standard methods
timeFrame: Death for any cause up until 30 days after inclusion
measure: Prediction of hospital admission using vital signs estimated using the new camera based method
timeFrame: Hospital admission for any cause up until 30 days after inclusion
measure: Prediction of death using vital signs estimated using the new camera based method
timeFrame: Death for any cause up until 30 days after inclusion
measure: Prediction of hospital admission using raw camera data
timeFrame: Hospital admission for any cause up until 30 days after inclusion
measure: Prediction of death using raw camera data
timeFrame: Death for any cause up until 30 days after inclusion
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Östra Sjukhuset
Study officials:
affiliation: Primary Health care, Regionhalsan, Region Vastra Gotaland, Sweden
name: Ronny K Gunnarsson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malmberg S, Khan T, Gunnarsson R, Jacobsson G, Sundvall PD. Remote investigation and assessment of vital signs (RIA-VS)-proof of concept for contactless estimation of blood pressure, pulse, respiratory rate, and oxygen saturation in patients with suspicion of COVID-19. Infect Dis (Lond). 2022 Sep;54(9):677-686. doi: 10.1080/23744235.2022.2080249. Epub 2022 Jun 1.