PyrexiaCOVID3TNCT04397380
COVID-19 Thales Thermography Triage : Thermal Camera Feasibility Study
An observational study of Pyrexia and COVID, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
Trial summary
This study will refine and pilot the feasibility of introducing a thermal imaging test to detect fever in 100 patients being triaged within the Emergency Department. The only additional research requirement for the patient is to have a thermal image of their face taken. Other triage tests will be routine. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Thermography and Tympanic Temperature
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2020to 1 Jul 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage
Who may be able to join
- Patients ≥ 16 years old
- Patients able to read and understand English
- Patients able to give informed consent
- Patients being triaged through ED for any complaint (not necessarily COVID-19)
Who cannot join
- Patients not meeting the inclusion criteria
- Patients who do not have capacity to consent
- Patients attending ED who are fast-tracked without triage
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, G52 4TF
David J Lowe, MBChB
Malcolm WG Gordon, MBChb
About this study
Official title: COVID-19 Response - Thermography Based Fever Detection for Triaging of Patients - A Feasibility Study
This study will refine and pilot the feasibility of introducing a thermal imaging test to detect fever in 100 patients being triaged within the Emergency Department. The only additional research requirement for the patient is to have a thermal image of their face taken. Other triage tests will be routine.
The aims of the feasibility study are to:
Read more
- Understand the acceptability of introducing the intervention within the Emergency Department setting
- Establish indicative patient recruitment numbers per week
- Determine the likely proportion of patients recruited from this group who have a high temperature
- Provide preliminary evidence that the technology can identify a high temperature in this diverse group of patients
- Provide preliminary data for machine learning training to support classification of patients as being with or without fever
The feasibility study will then inform the design and size of larger study to further develop and validate the the thermal imaging screening test to provide a 'with/ without' fever result.
Read the detailed description
Justification for research and project plan Background In the fifty years since the emergence of thermal imaging technology, Thales in Glasgow has built up a world leading capability in the design, manufacture and supply of Thermal Imaging cameras. In addition to the cameras, Thales in Glasgow has a particular expertise in developing image processing algorithms (conventional and artificial intelligence based) to allow the cameras to perform critical user tasks beyond mere imaging.
COVID-19 [SARS-COV-2] has placed a huge challenge on the world. In response to the crisis, Thales is engaged in a number of initiatives, including one aimed at the possible application of thermal imaging cameras to detect people with a fever and hence those who may be suffering from COVID-19. This initiative has received encouraging feedback from prospective users around the world who are looking, not only at the immediate issue in the hospitals, but also forward to a time beyond the current lockdowns, when cost effective techniques for surveying groups of people for potential COVID-19 sufferers will be required. This surveillance, for example, could be in hospitals, at airport gates, in buildings or outside in streets. As part of the initiative Thales Glasgow has been performing analysis and experiments using cameras looking at faces to confirm what temperature differences can be measured.
What Thales lacks is real world thermal images of patients suffering fever and access to clinicians who can advise on the medical aspects of the work. This research would fill these two voids.
Benefit and Rationale Existing thermal camera based fever detection systems suffer from two main issues that restrict their current application: Cost and Sensitivity.In order to achieve the required sensitivity, existing systems often require Black Body (BB) calibration sources to be visible in the scene. These BB sources are often more expensive than the cameras (circa one to two orders of magnitude more expensive). Thales believe they can achieve the required sensitivity without the need for BB sources by using advanced thermal camera correction algorithms.
The variability in skin emissivity makes conversions from irradiance as measured by a thermal camera, to absolute skin temperature inaccurate. Previous work place the emissivity of human skin between 0.990 and 0.999, however earlier research suggests that the value is 0.971 ± 0.005(SD). Typically in existing systems, this inaccurate, absolute temperature is used along with a simple threshold algorithm to find skin above a certain temperature leading to both false positives and false negatives.
Significant statistical correlation between the temperature of multiple facial features and measured human temperature has been observed. Their research found that for most facial features there was a correlation between multiple aspects of the facial view and recorded oral and tympanic temperature, with correlations of 0.5 or greater observed for multiple aspects of both the front and side of the face, with the ear offering the greatest statistical correlation.
- Being tested
- Thermography, Tympanic Temperature
- Keywords
- Thermography
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyDevice
Measure Temperature using Thermal Camera
Tympanic TemperatureDevice
Measure Temperature using Tympanic Temperature
| Study group | Role | What they receive |
|---|---|---|
| ED Patients | Patients Presenting in Emergency Department Receives: Device: Thermography; Device: Tympanic Temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature
Measurement of temperature
Measured: During Emergency Department Stay (first 4 hours of hospitalisation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start20 May 2020 (estimated)
- Primary completion3 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyrexiaStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Clyde and Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Lowe, NHS Greater Clyde and Glasgow
- Investigators
- David J Lowe, MBChB, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397380
- Sponsor's protocol ID
- INGC20AE209
- Acronym
- COVID3T
- Status last verified
- May 2020
- First submitted
- 16 May 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Response - Thermography Based Fever Detection for Triaging of Patients - A Feasibility Study
- ClinicalTrials.gov ID
- NCT04397380
- Acronym / sponsor ID
- COVID3T / INGC20AE209
- Keywords
- Thermography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NHS Greater Clyde and GlasgowUniversity, hospital or other
- Study start
- 20 May 2020 (estimated)
- Primary completion
- 3 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 21 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.
This study will refine and pilot the feasibility of introducing a thermal imaging test to detect fever in 100 patients being triaged within the Emergency Department. The only additional research requirement for the patient is to have a thermal image of their face taken. Other triage tests will be routine.
The aims of the feasibility study are to:
- Understand the acceptability of introducing the intervention within the Emergency Department setting
- Establish indicative patient recruitment numbers per week
- Determine the likely proportion of patients recruited from this group who have a high temperature
- Provide preliminary evidence that the technology can identify a high temperature in this diverse group of patients
- Provide preliminary data for machine learning training to support classification of patients as being with or without fever
The feasibility study will then inform the design and size of larger study to further develop and validate the the thermal imaging screening test to provide a 'with/ without' fever result.
Detailed description
Justification for research and project plan Background In the fifty years since the emergence of thermal imaging technology, Thales in Glasgow has built up a world leading capability in the design, manufacture and supply of Thermal Imaging cameras. In addition to the cameras, Thales in Glasgow has a particular expertise in developing image processing algorithms (conventional and artificial intelligence based) to allow the cameras to perform critical user tasks beyond mere imaging.
COVID-19 [SARS-COV-2] has placed a huge challenge on the world. In response to the crisis, Thales is engaged in a number of initiatives, including one aimed at the possible application of thermal imaging cameras to detect people with a fever and hence those who may be suffering from COVID-19. This initiative has received encouraging feedback from prospective users around the world who are looking, not only at the immediate issue in the hospitals, but also forward to a time beyond the current lockdowns, when cost effective techniques for surveying groups of people for potential COVID-19 sufferers will be required. This surveillance, for example, could be in hospitals, at airport gates, in buildings or outside in streets. As part of the initiative Thales Glasgow has been performing analysis and experiments using cameras looking at faces to confirm what temperature differences can be measured.
What Thales lacks is real world thermal images of patients suffering fever and access to clinicians who can advise on the medical aspects of the work. This research would fill these two voids.
Benefit and Rationale Existing thermal camera based fever detection systems suffer from two main issues that restrict their current application: Cost and Sensitivity.In order to achieve the required sensitivity, existing systems often require Black Body (BB) calibration sources to be visible in the scene. These BB sources are often more expensive than the cameras (circa one to two orders of magnitude more expensive). Thales believe they can achieve the required sensitivity without the need for BB sources by using advanced thermal camera correction algorithms.
The variability in skin emissivity makes conversions from irradiance as measured by a thermal camera, to absolute skin temperature inaccurate. Previous work place the emissivity of human skin between 0.990 and 0.999, however earlier research suggests that the value is 0.971 ± 0.005(SD). Typically in existing systems, this inaccurate, absolute temperature is used along with a simple threshold algorithm to find skin above a certain temperature leading to both false positives and false negatives.
Significant statistical correlation between the temperature of multiple facial features and measured human temperature has been observed. Their research found that for most facial features there was a correlation between multiple aspects of the facial view and recorded oral and tympanic temperature, with correlations of 0.5 or greater observed for multiple aspects of both the front and side of the face, with the ear offering the greatest statistical correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED Patients | – | Device: Thermography, Device: Tympanic TemperaturePatients Presenting in Emergency Department |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage
Key inclusion criteria (4 listed)
- Patients ≥ 16 years old
- Patients able to read and understand English
- Patients able to give informed consent
- Patients being triaged through ED for any complaint (not necessarily COVID-19)
Key exclusion criteria (3 listed)
- Patients not meeting the inclusion criteria
- Patients who do not have capacity to consent
- Patients attending ED who are fast-tracked without triage
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 |
|---|---|---|
| ThermographyMeasure Temperature using Thermal Camera | Device | ED Patients |
| Tympanic TemperatureMeasure Temperature using Tympanic Temperature | Device | ED Patients |
Primary outcome
Temperature
Time frame: During Emergency Department Stay (first 4 hours of hospitalisation)
Measurement of temperature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
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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.
David J Lowe, MBChB principal investigator
NHS Greater Glasgow and Clyde
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 Pyrexia and COVID, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 May 2020. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Lowe, MBChB (01414522930, david.lowe@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperature (time frame: During Emergency Department Stay (first 4 hours of hospitalisation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.