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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in United Kingdom

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 groups in NCT04792450
Study groupRoleWhat they receive
ED PatientsPatients presenting in Emergency Department
Receives: Device: Thermography; Device: Tympanic Thermometer; Device: Forehead Thermometer; Device: 62 Max + Infra-red thermometer
ED StaffStaff 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.

  1. 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.

  1. First posted11 Mar 2021
  2. Study start1 Nov 2020
  3. Primary completion15 Dec 2020
  4. Study completionMay 2021 (estimated)

Resources

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
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

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.

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