Thales Thermography Triage (3T) - Pilot Project: Developing a Thermal Camera That Accurately Records Participants' Temperature From Images of Their Face
Conditions: Fever
Sponsor: NHS Greater Clyde and Glasgow

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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Thales Thermography Triage (3T) – Pilot Project 
 
Short Title: Developing a thermal camera that accurately records participants’ temperature from  
images of their face 
 
 
Investigators:  
 
Chief Investigator: 
Dr David Lowe, QEUH, NHSGGC  
Co-investigators: 
Dr Iain D. Carrie (Thales UK) 
Dr Barry Connor (Thales UK) 
William Alexander (Thales UK) 
ClinicalTrials.gov ID 
 
 
Sponsor: Thales UK 
 
Address: 350 Longwater Avenue, Green Park, Reading, Berks RG2 6GF 
 
 
Protocol Reference: 
 
Version Number & Date:  
Version 2, 9 September 2020 
Effective Date: 
TBD 
 
Superseded Version 
Number & Date (If 
applicable) 
- 
 
 
 
IRAS Number: 287901 
 
Sponsor Reference Number: INGC20AE396 
 
 
 
 

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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Contents 
 
 
Section: 
 
 
 
 
 
 
         
 
 
 
 
 
 
 
 
 
1. Background 
2. Aims 
3. Research questions 
 
 
 
4. Study Design (inclusion, patient identification, study procedures, F/U) 
 
 
5. Withdrawal 
6. Data handling, analysis and archival 
7. Regulatory & Ethics Committee Approval 
 
8. Data protection and patient confidentiality  
9. Indemnity 
10. Dissemination and publication policy 
 
11. References 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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1.   Background:  
In the fifty years since the emergence of thermal imaging technology, Thales has built up a 
world leading capability in the design, manufacture and supply of Thermal Imaging cameras. 
In addition to the cameras, Thales has a particular expertise in developing image processing 
algorithms (conventional and artificial intelligence based) to allow the cameras and systems 
to perform critical user tasks beyond mere imaging.   
 
Thermal imaging cameras have been used to screen for fever as a potential indication of 
pathogenic infection in transportation hubs since the early 2000’s, especially in countries 
that dealt with SARS. Fever is a key symptom of covid-19 (ref). 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.  
 
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 (Ref) which captures Infrared radiation 
emitted by the tympanic membrane in the ear. (Figure 1) 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. 
 
 
 
Figure 1: Distribution of variance between measurements for each subject for tympanic 
thermometer and HTD (n = 80) 
 

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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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. 
 
 
 
 
Figure 2: Temperature Measurement vs Actual 
 
Figure 2 shows that the thermometer (juniper) in forehead mode appeared to return measured 
temperature + an offset to estimate core.   The HTD can be calibrated in the same way i.e. to 
use the actual forehead temperature returned from the HTD plus the same offset.  For 
tympanic comparison, the maximum temperature returned by the HTD (probably the canthus) 
correlates best – but it is still likely that some post processing will be required to ensure that a 
direct comparison can be made. 
 
2.  Aims 
 
The Thales HTD (High Temperature Detection) System is a thermal camera based, human 
temperature measurement system. 
 
This study will compare the HTD system with the two routinely used temperature 
measurement systems (tympanic and forehead) to understand the level of agreement that can 
be achieved and so its potential utility in triage and in a transportation and workplace setting.  A 
secondary objective of this study are to assess if skin tone adds any additional differences 

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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between a thermal camera based system temperature assessment and the routinely used 
tympanic and forehead based methods.  
 
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.   
 
100 staff and 100 patients will be consented with thermal images of their face taken as well as 
having their temperatures taken. The following measurements and information will be 
recorded: 
 
•            Forehead temperature from the HTD System 
•            Head temperature from the HTD System 
•            Tympanic temperature from a tympanic IR thermometer  
•            Forehead temperature from a forehead IR thermometer  
•            Age  
•            Ethnicity 
 
A sample of size 100 will give 95% confidence intervals for the limits of agreement of +/- 0.34 
standard deviations (https://www-users.york.ac.uk/~mb55/meas/sizemeth. ). These limits of 
agreement will then allow determination of how close the temperature readings are between 
1. Tympanic vs. HTD and 2. Forehead vs HTD and whether or not these are within +/- 0.2 
degrees. It will demonstrate if there is a trend over the temperature range to understand 
consistency. The bias will be quantified using the mean difference (significance determined 
using a t-test).  
 
The larger sample size (200) is proposed to gather a wider range of skin tone measures. Staff 
members will be recruited in addition to patients as this is likely to increase the diversity of the 
sample. 
 
Although a BB source is not required for the new HTD system, a BB will be housed in the room 
where staff measurements are taken. Its inclusion gives another source of ground truth and 
will allow the calibration of all systems to be checked at regular intervals throughout the study. 
 
 
3. Research Questions  
 
Primary 
 
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.  
 
 
Secondary 
 
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 
 
 

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4. Study Design  
 
Patient Identification 
 
Two groups will be identified 
1. Patients who present to the Emergency Department (ED) in QEUH will be 
approached either by ED nurses or clinical fellows they can approach reception 
staff/nurse directly for information after reading posters on the ED wall.   
 
2. QEUH ED staff will be approached either by ED nurses or clinical fellow. 
 
 
Inclusion criteria  
 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 
 
Exclusion criteria 
 
Patients not meeting the inclusion criteria 
 
Patients who do not have capacity to consent 
 
Patients attending ED who are fast-tracked without triage 
 
 
Consent 
Participants will be given a participant information sheet (PIS v2) to read while they are 
in waiting to be triaged (patients) or working in the ED (staff).  There will be posters 
displayed publicising the study, and if people are interested they can ask reception staff 
or a nurse for more information.  The nurse or fellow will go through the PIS and 
provide opportunity to ask questions. Due to the circumstances there is no opportunity 
for patients to take the PIS away and discuss it with friends/family which would be 
preferred.  If the patient/staff member wishes to participate, a consent form will be 
provided which has some statements to agree to and sign.  The participant can keep a 
copy of the signed consent form as well as the PIS. Failure to consent will not change 
clinical care for patients.  
 
The PIS will make it clear that Thales will hold a copy of the identifiable images for a 
maximum of 1 year.  Thales will securely store and analyse visible and thermal data 
required for future algorithm upgrades. It is anticipated that Thales will require to hold 
onto both visible and thermal data long enough to be required for regulatory 
purposes.  For example, it is anticipated that the thermal data, and associated 
metadata, will be required for a maximum of ten years and the visible data for a 
maximum of one year, after which time the data will be securely destroyed. 
 
 
 
Study procedures 
 
After the participant has consented to take part, the research will take a front view 
with the thermal imaging camera.  The following data is routinely collected at triage 
and a copy of the data will also be entered into the Thales electronic Case Report Form 
(eCRF).  No patient name or personal details will be held by Thales.   

Thales Thermography Study Protocol:  V2  09.09.20 
 
 
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- 
Temperature 
 
Oral 
 
IR Forehead 
 
Ear 
- 
History of Fever Y/N 
- 
Age  
- 
Ethnicity 
- 
If they are wearing contact lenses 
 
While desirable to have uncovered face thermal images, it is accepted that some 
patients may choose to wear facemasks. Patients will be asked to remove spectacles. 
 
It is expected that the thermal imaging system will sit on a table or worktop and image 
patients approximately 1.5m to 2.0m away.  The system will require access to a mains 
wall socket. The kit will remain set up in a locked room when not being used.  
 
The system will comprise of: 
• 
Surface Pro Tablet PC; 
• 
Thales camera mounted on a portable tripod; 
• 
Thermal calibration Black Body source (for calibration validation purposes 
only). 
• 
MiFi internet connection 
• 
Forehead thermometer 
• 
Tympanic thermometer  
 
The tablet will auto-run easy to use software allowing hospital staff to record: 
• 
Thermal and TV image of the patient front on; 
• 
Non-personal patient metadata: 
- 
Patient temperature measured by existing clinical methods 
  
The system will be simple to use and aims to minimise the disruption of the QEUH staff. 
Thales will have provided training of QEUH staff on how to operate the equipment and 
support of the equipment during the data collection activity. Training will take the form 
of a pdf, training video and if required a video conference call. 
 
 
Follow Up  
 
 
There is no follow up required – patients are only required to commit to one hospital 
visit when they initially present at ED and have their picture taken with the thermal 
imaging camera. Staff will require only to have their picture taken.   
 
5. Withdrawal 
If participants wish to withdraw their consent after the intervention (after the image has been 
taken) they can do so and it will not affect their clinical treatment.  They may withdraw from 
the study at their own request and are not required to give a reason for this. They will be made 
aware that this will not affect their future care.  Participants will be made aware that should 
they withdraw the data collected to date will be retained and used in the final analysis.  
 

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6. Data handling, analysis and archival 
 
Data Handing 
All the information obtained about participants in the course of the study is confidential and 
will be held in accordance with the General Data Protection Regulation (GDPR 2018).  Data will 
be entered into a custom graphical user interface (GUI). Once the images and metadata have 
been recorded they will be regularly and periodically encrypted and then the unencrypted 
images deleted from the device automatically. Encrypted data will by synced with an encrypted 
dropbox and then transferred to Thales secure servers. Data will be unencrypted when it 
reaches the secure Thales servers. 
 
Data are stored on dedicated storage area implementing Mandatory Access Control for an 
explicit list of authorised users. The management of those IT resources are performed by Thales 
UK ltd. Thales UK ltd is certified against the Cyber Essential Plus scheme.  
 
Data Analysis 
Personal data will be collected and processed only for the purpose of answering the research 
questions. The thermal images are Personally Identifiable Information (PII) and will be retained 
by the company for as short a time as possible before being permanently deleted. The other 
data items are not PII and are low risk in terms of identifying the patient from anonymised data.  
Personal information will not be shared with anybody outside the study.  
 
The feasibility study data will primarily be analysed using statistical methods looking for 
relationships between facial feature temperatures and patient metadata. Artificial Intelligence 
(AI) /Convolutional Neural Network (CNN) based feature detection algorithms may be used to 
find the coordinates of the key points on the face in the visible image. The corresponding 
coordinates can be found with fine camera alignment and calibration. The thermal features 
may then be extracted for analysis along with the patient metadata.  A manual feature 
extraction method may be used instead of the AI/CCN method if deemed more efficient for the 
smaller, initial dataset of 200 patients.  Manual inspection of thermal images will be used to 
look for patterns and anomalies.    
 
 Three readings will be done per participant and comparisons done between:-  
  
1.       Tympanic vs. Thermal 
2.       IR vs. Thermal 
 
A sample of size 100 will give 95% CIs for the limits of agreement of +/- 0.34 standard deviations 
(i.e. about a third of the standard deviation) 
 
A sample of size 200 will give 95% CIs for the limits of agreement of +/- 0.24 standard deviations 
(i.e. about a quarter of the standard deviation) 
  
Accuracy for other pre-defined sample sizes can be computed as +/- 1.96 sqrt(3/n) as the 
multiplier of the standard deviation. 
 
 
 
 

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Data Archival 
The participants will be allocated a unique ID number. Hardcopies of patient consent data and 
the patient identity/ study identifier key will be held in the ED site file and archived locally when 
the study is finished.  
 
Only authorised research personnel will have access to the data collected in this study.  They 
may also be looked at by representatives of regulatory authorities and by authorised people 
from NHS Greater Glasgow & Clyde and if an audit is required for quality assurance purposes. 
All will have a duty of confidentiality to research participants. 
 
 
 
7. Regulatory & Ethics Committee Approval 
 
 
The study shall not commence until the study protocol, information sheet and consent form 
have been reviewed and approved from a Research Ethics Committee and relevant NHS 
permission is obtained.  
 
The sponsor will be responsible for deciding whether any protocol amendments are substantial 
and non-substantial in collaboration with the Chief Investigator.  Where an amendment is 
required to study documentation that requires REC approval, changes will not be implemented 
until REC approval is received and local permission confirmed. Should an amendment be 
required to eliminate an apparent immediate hazard to participants this may be implemented 
immediately and the REC and R&D notified as soon as is possible. Minor amendments for 
logistical or administrative purposes may be implemented immediately.  Amendments will be 
logged on the Sponsor’s Study Amendment Log and stored in the Trial Master/Site File(s).  
 
Annual Progress Reports shall be submitted to the REC within 30 days of the anniversary date 
on which the favourable opinion was given – until the end of the study. A final report shall 
(where possible) be submitted to the REC within one year after the end of the study.  If the 
study is terminated prematurely the CI will notify the REC, including the reasons for premature 
termination.  
 
 
 
8. Data protection and patient confidentiality  
 
All study staff and investigators will comply with the principles of the Data Protection Act 2018 
in protecting the rights of study participants with regards to the collection, storage, processing 
and disclosure of personal information and will uphold the Act’s/Regulations core principles.  
 
Each participant will be assigned a study identity number, for use on all trial documents and 
the electronic database.  Other than the identifiable images, no personally identifiable 
Information will be stored. The identifiable images will be deleted as soon as possible – but 
certainly within 1 year.  However, for the avoidance of doubt, all other unidentifiable images 
will be stored for up to 10 years. Very limited research data is required and this will be stored 
using the study identity number. Thales will not hold a key. The site will hold the key within the 
local site file until to link the images and the data, and this will be archived locally.   
 
All data will be automatically encrypted shortly after acquisition. Original, unencrypted images 
will be securely deleted. All encrypted data will be held on the password protected tablet PC 
during the trial for backup purposes.  All encrypted data will be synced with an encrypted 

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dropbox. The encrypted data will be placed on secure Thales servers and stored within 
password protected folders. Data will then be unencrypted for analysis. 
 
Personal data will be stored for 10 years following the end of the study, so that the Chief 
Investigator may provide participants with a summary of the research (should they wish to 
receive a copy). Data generated as a result of this study will be available for inspection on 
request by NHS Greater Glasgow & Clyde, the REC, local R&D Departments and the regulatory 
authorities. 
 
 
9. Indemnity 
 
Insurance and indemnity for trial participants and trial staff is covered within the NHS 
Indemnity Arrangements for clinical negligence claims in the NHS. There are no special 
compensation arrangements, but trial participants may have recourse through the NHS 
complaints procedures. 
 
 
10. Dissemination of results and publication  
 
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 - with a fever "yes/no" result.  Nonetheless 
preliminary results may be publishable in a peer reviewed journal. 
 
11. 
References 
Allam Z, Jones DS. On the coronavirus (COVID-19) outbreak and the smart city network: 
universal data sharing standards coupled with artificial intelligence (AI) to benefit urban health 
monitoring and management. InHealthcare 2020 Mar (Vol. 8, No. 1, p. 46). Multidisciplinary 
Digital Publishing Institute. 
 
Lee IK, Wang CC, Lin MC, Kung CT, Lan KC, Lee CT. Effective strategies to prevent 
coronavirus disease-2019 (COVID-19) outbreak in hospital. Journal of Hospital Infection. 2020 
Mar 3. 
 
Royal College of Physicians. National Early Warning Score (NEWS) 2 standardising the 
assessment of acute-illness severity in the NHS (2017). Available at: 
<https://www.rcplondon.ac.uk/projects/outputs/national-early-warning-score-news-2> 
(accessed 5 May 2020).