Covid-19 Triage Using Camera-based AI

Coronavirus Infections Clinical Trial

Official title:

Covid-19 Triage Using Camera-based AI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383457
• Other study ID #: U1111-1251-4114
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: October 8, 2020

Study information

• Verified date: November 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections

Intervention

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.

Locations

Country	Name	City	State
Sweden	Östra Sjukhuset	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Detectivio AB

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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 suspicio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between the new camera based method and reference standard to estimate body temperature	Body temperature will be measured with the new camera based method as well as with a conventional ear thermometer. Both measurements will estimate the body temperature in degrees Celsius. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Primary	Agreement between the new camera based method and reference standard to estimate heart rate	Heart rate will be measured with the new camera based method as well as with a conventional apparatus for measuring pulse rate. Both measurements will estimate the heart rate in beats per minute. The agreement between body temperature estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Primary	Agreement between the new camera based method and reference standard to estimate blood oxygen saturation	Blood oxygen saturation will be measured with the new camera based method as well as with a conventional apparatus for measuring blood oxygen saturation. Both measurements will estimate the blood oxygen saturation in percent (ranging from 0-100%). The agreement between blood oxygen saturation estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Primary	Agreement between the new camera based method and reference standard to estimate systolic blood pressure	Systolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring systolic blood pressure. Both measurements will estimate the systolic blood pressure in mm Hg. The agreement between systolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Primary	Agreement between the new camera based method and reference standard to estimate diastolic blood pressure	Diastolic blood pressure will be measured with the new camera based method as well as with a conventional apparatus for measuring diastolic blood pressure. Both measurements will estimate the diastolic blood pressure in mm Hg. The agreement between diastolic blood pressure estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Primary	Agreement between the new camera based method and reference standard to estimate respiratory rate	Respiratory rate will be measured with the new camera based method as well as manually using a stethoscope. Both measurements will estimate the respiratory rate in breath per minute. The agreement between respiratory rate estimated with the new method and the reference method will be made using the statistical methods Bland-Altman plots and limits of agreement as the outcome.	Two minutes between measurements
Secondary	Prediction of hospital admission using vital signs estimated using reference standard methods	An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Hospital admission for any cause up until 30 days after inclusion
Secondary	Prediction of death using vital signs estimated using reference standard methods	An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Death for any cause up until 30 days after inclusion
Secondary	Prediction of hospital admission using vital signs estimated using the new camera based method	An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Hospital admission for any cause up until 30 days after inclusion
Secondary	Prediction of death using vital signs estimated using the new camera based method	An artificial intelligence (AI) algorithm will use 75% of patient observations of vital signs for training and the remaining 25% will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for hospitalization within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Death for any cause up until 30 days after inclusion
Secondary	Prediction of hospital admission using raw camera data	An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict hospital admission within 30 days. For each patient the AI will produce a probability (0-100%) for hospital admission within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Hospital admission for any cause up until 30 days after inclusion
Secondary	Prediction of death using raw camera data	An artificial intelligence (AI) algorithm will use 75% of patient observations of raw camera data for training and raw data from the remaining 25% of patients will be used to test the AIs predictive capabilities to predict death within 30 days. For each patient the AI will produce a probability (0-100%) for death within 30 days. These probabilities will undergo a receiver operating (ROC) analysis where area under curve (AUC) with 95% confidence interval will be the reported outcome measure.	Death for any cause up until 30 days after inclusion