FeverNCT04792450
Thales Thermography Triage (3T) - Pilot Project
An observational study of Fever, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
Trial summary
COVID Related Study. This study will compare the Thales High Temperature Detection (HTD) system with the two routinely used temperature measurement systems (tympanic and forehead) in patients and staff in the Emergency Department. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fever
- What is being tested?
- Thermography, Tympanic Thermometer and Forehead Thermometer
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to May 2021
- How long will I take part?
- 1 Day
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage. All staff members working within Queen Elizabeth University Hospital Emergency Department.
Who may be able to join
- Patients ≥ 16 years old with no upper age limit
- 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 QEUH ED staff
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
About this study
Official title: Thales Thermography Triage (3T) - Pilot Project: Developing a Thermal Camera That Accurately Records Participants' Temperature From Images of Their Face
COVID Related Study.
This study will compare the Thales High Temperature Detection (HTD) system with the two routinely used temperature measurement systems (tympanic and forehead) in patients and staff in the Emergency Department.
Read more
The aims of the study are:
- To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C.
- To determine if skin tone is an independent confounding factor in the measurement of fever using HTD
- To establish performance of internal calibration of Thales device
- To power for a definitive Clinical Investigation to determine clinical efficacy and safety cut off with HTD If results are encouraging the aim would then be to undertake a clinical investigation in order to get CE marking for use in a clinical setting.
Read the detailed description
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.Fever is a key symptom of covid-19. One of the major limitations of existing systems is thermographic accuracy. Most current thermographic camera systems offer an accuracy of ± 0.5°C. This can be reduced to ±0.3°C with the inclusion of a "Black Body" calibration source, although this limits the portability of the system. Using their unique knowledge and expertise in high resolution and precision thermal imaging and thermal image processing, Thales aims to develop a fever screening system with an accuracy of ± 0.1°C to enable more effective identification and triage of people with fever.
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.
In a pilot study conducted in the Emergency Department, Queen Elizabeth University Hospital (20/NS/0064), the Thales High Temperature Detection (HTD) system was found to be more accurate than a tympanic thermometer which captures Infrared radiation emitted by the tympanic membrane in the ear or forehead thermometer. Tympanic temperature measurements are typically used in the hospital setting in Scotland whereas forehead IR measurement is common in transportation and workplace settings.
The HTD has been redesigned in response to three key findings from the pilot study:
- The relative temperature of some facial features correlated more strongly with tympanic temperature than others.
- Having an external Black Body (BB) calibration source in the scene at all times was impractical in a clinical environment
- Camera systems require to be compact and portable to be useful to clinical staff.
As a result, the HTD is now significantly reduced in size, including peripheral devices. A novel calibration solution has been designed (and patented) that not only removes the need for the black body source but allows for a more accurate temperature evaluation. In addition, facial feature detection has been integrated into the software to allow it to automatically locate the patient's head and in the near future, automatically determine the temperatures of individual facial features. This development will capture facial feature detection - not facial recognition.
- Conditions
- Fever
- Being tested
- Thermography, Tympanic Thermometer, Forehead Thermometer, 62 Max + Infra-red thermometer
- 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 ThermometerDevice
Measure Temperature using Tympanic Thermometer
Forehead ThermometerDevice
Measure Temperature using Forehead Temperature
62 Max + Infra-red thermometerDevice
Measure Temperature using 62 Max + Infra-red thermometer
| Study group | Role | What they receive |
|---|---|---|
| ED Patients | Patients presenting in Emergency Department Receives: Device: Thermography; Device: Tympanic Thermometer; Device: Forehead Thermometer; Device: 62 Max + Infra-red thermometer | |
| ED Staff | Staff working within the Emergency Department Receives: Device: Thermography; Device: Tympanic Thermometer; Device: Forehead Thermometer; Device: 62 Max + Infra-red thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C.
Measurement of temperature in celsius
Measured: 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 posted11 Mar 2021
- Study start1 Nov 2020
- Primary completion15 Dec 2020
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- NHS Greater Clyde and Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Thales Group
- Responsible party
- Principal investigator, David Lowe, NHS Greater Clyde and Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792450
- Sponsor's protocol ID
- 287901
- Status last verified
- Mar 2021
- First submitted
- 25 Sep 2020
- Last updated
- 11 Mar 2021
- Results posted
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thales Thermography Triage (3T) - Pilot Project: Developing a Thermal Camera That Accurately Records Participants' Temperature From Images of Their Face
- ClinicalTrials.gov ID
- NCT04792450
- Acronym / sponsor ID
- 287901
- Conditions
- Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NHS Greater Clyde and GlasgowUniversity, hospital or other
- Collaborators
- Thales Group
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 11 Mar 2021 (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.
COVID Related Study.
This study will compare the Thales High Temperature Detection (HTD) system with the two routinely used temperature measurement systems (tympanic and forehead) in patients and staff in the Emergency Department.
The aims of the study are:
- To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C.
- To determine if skin tone is an independent confounding factor in the measurement of fever using HTD
- To establish performance of internal calibration of Thales device
- To power for a definitive Clinical Investigation to determine clinical efficacy and safety cut off with HTD If results are encouraging the aim would then be to undertake a clinical investigation in order to get CE marking for use in a clinical setting.
Detailed description
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.Fever is a key symptom of covid-19. One of the major limitations of existing systems is thermographic accuracy. Most current thermographic camera systems offer an accuracy of ± 0.5°C. This can be reduced to ±0.3°C with the inclusion of a "Black Body" calibration source, although this limits the portability of the system. Using their unique knowledge and expertise in high resolution and precision thermal imaging and thermal image processing, Thales aims to develop a fever screening system with an accuracy of ± 0.1°C to enable more effective identification and triage of people with fever.
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.
In a pilot study conducted in the Emergency Department, Queen Elizabeth University Hospital (20/NS/0064), the Thales High Temperature Detection (HTD) system was found to be more accurate than a tympanic thermometer which captures Infrared radiation emitted by the tympanic membrane in the ear or forehead thermometer. Tympanic temperature measurements are typically used in the hospital setting in Scotland whereas forehead IR measurement is common in transportation and workplace settings.
The HTD has been redesigned in response to three key findings from the pilot study:
- The relative temperature of some facial features correlated more strongly with tympanic temperature than others.
- Having an external Black Body (BB) calibration source in the scene at all times was impractical in a clinical environment
- Camera systems require to be compact and portable to be useful to clinical staff.
As a result, the HTD is now significantly reduced in size, including peripheral devices. A novel calibration solution has been designed (and patented) that not only removes the need for the black body source but allows for a more accurate temperature evaluation. In addition, facial feature detection has been integrated into the software to allow it to automatically locate the patient's head and in the near future, automatically determine the temperatures of individual facial features. This development will capture facial feature detection - not facial recognition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED Patients | – | Device: Thermography, Device: Tympanic Thermometer, Device: Forehead Thermometer, Device: 62 Max + Infra-red thermometerPatients presenting in Emergency Department |
| ED Staff | – | Device: Thermography, Device: Tympanic Thermometer, Device: Forehead Thermometer, Device: 62 Max + Infra-red thermometerStaff working within the Emergency Department |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage. All staff members working within Queen Elizabeth University Hospital Emergency Department.
Key inclusion criteria (4 listed)
- Patients ≥ 16 years old with no upper age limit
- 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 QEUH ED staff
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, ED Staff |
| Tympanic ThermometerMeasure Temperature using Tympanic Thermometer | Device | ED Patients, ED Staff |
| Forehead ThermometerMeasure Temperature using Forehead Temperature | Device | ED Patients, ED Staff |
| 62 Max + Infra-red thermometerMeasure Temperature using 62 Max + Infra-red thermometer | Device | ED Patients, ED Staff |
Primary outcome
To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C.
Time frame: First 4 hours of hospitalisation.
Measurement of temperature in celsius
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fever, 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 11 Mar 2021. 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?
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?
To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C. (time frame: 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 11 Mar 2021.