Coronavirus InfectionsNCT04383457
Covid-19 Triage Using Camera-based AI
An observational study of Coronavirus Infections, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Infections
- What is being tested?
- RIA-device (Remote Investigation and Assessment)
- Type of treatment
- Medical device
- How many people
- 214 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2020to 8 Oct 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients attending the emergency department at Östra sjukhuset Gothenburg for a suspected infection.
Who may be able to join
- The patient is attending for triage presenting with symptoms of an infection.
- Subject has provided informed consent
- Age ≥18 years
- Fluent in Swedish (reading, writing, conversational)
- 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
- The investigator determines that the new method, and the reference methods, can be used as intended with adequate reliability and safety
- 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.
Who cannot join
- Depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes).
- Patient request to be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Coronavirus Infections
- Being tested
- RIA-device (Remote Investigation and Assessment)
- Keywords
- Vital signs, Pulse, Blood pressure, Respiratory rate, Oxygen saturation, Temperature
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIA-device (Remote Investigation and Assessment)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two minutes between measurements
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.
Measured: Two minutes between measurements
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.
Measured: Two minutes between measurements
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.
Measured: Two minutes between measurements
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.
Measured: Two minutes between measurements
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.
Measured: Two minutes between measurements
Secondary outcomes (6)
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.
Measured: Hospital admission for any cause up until 30 days after inclusion
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.
Measured: Death for any cause up until 30 days after inclusion
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.
Measured: Hospital admission for any cause up until 30 days after inclusion
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.
Measured: Death for any cause up until 30 days after inclusion
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.
Measured: Hospital admission for any cause up until 30 days after inclusion
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.
Measured: Death for any cause up until 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start15 Jun 2020
- Primary completion8 Oct 2020
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Detectivio AB
- Responsible party
- Sponsor
- Investigators
- Ronny K Gunnarsson, MD PhD, Principal investigator, Primary Health care, Regionhalsan, Region Vastra Gotaland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383457
- Sponsor's protocol ID
- U1111-1251-4114
- Status last verified
- Nov 2020
- First submitted
- 4 May 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from patients observations
Publications
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.
PubMed 35651319
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Covid-19 Triage Using Camera-based AI
- ClinicalTrials.gov ID
- NCT04383457
- Acronym / sponsor ID
- U1111-1251-4114
- Conditions
- Coronavirus Infections
- Keywords
- Vital signs, Pulse, Blood pressure, Respiratory rate, Oxygen saturation, Temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Detectivio AB
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending the emergency department at Östra sjukhuset Gothenburg for a suspected infection.
Key inclusion criteria (7 listed)
- The patient is attending for triage presenting with symptoms of an infection.
- Subject has provided informed consent
- Age ≥18 years
- Fluent in Swedish (reading, writing, conversational)
- 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
Key exclusion criteria (2 listed)
- Depressed level of consciousness from inclusion up until all investigations are completed (during approximately 15-20 minutes).
- Patient request to be withdrawn from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Agreement between the new camera based method and reference standard to estimate body temperature
Time frame: Two minutes between measurements
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.
Agreement between the new camera based method and reference standard to estimate heart rate
Time frame: Two minutes between measurements
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.
Agreement between the new camera based method and reference standard to estimate blood oxygen saturation
Time frame: Two minutes between measurements
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.
Agreement between the new camera based method and reference standard to estimate systolic blood pressure
Time frame: Two minutes between measurements
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.
Agreement between the new camera based method and reference standard to estimate diastolic blood pressure
Time frame: Two minutes between measurements
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.
Agreement between the new camera based method and reference standard to estimate respiratory rate
Time frame: Two minutes between measurements
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.
6 secondary outcomes
Prediction of hospital admission using vital signs estimated using reference standard methods
Time frame: Hospital admission for any cause up until 30 days after inclusion
Prediction of death using vital signs estimated using reference standard methods
Time frame: Death for any cause up until 30 days after inclusion
Prediction of hospital admission using vital signs estimated using the new camera based method
Time frame: Hospital admission for any cause up until 30 days after inclusion
Prediction of death using vital signs estimated using the new camera based method
Time frame: Death for any cause up until 30 days after inclusion
Prediction of hospital admission using raw camera data
Time frame: Hospital admission for any cause up until 30 days after inclusion
Prediction of death using raw camera data
Time frame: Death for any cause up until 30 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Results publication: PubMed 35651319Malmberg 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.
- Individual participant dataSharing planned: Yes. De-identified data from patients observations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronny K Gunnarsson, MD PhD principal investigator
Primary Health care, Regionhalsan, Region Vastra Gotaland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infections, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the new camera based method and reference standard to estimate body temperature (time frame: Two minutes between measurements). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04383457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.