Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04792450
Study type Observational [Patient Registry]
Source NHS Greater Clyde and Glasgow
Contact
Status Active, not recruiting
Phase
Start date November 1, 2020
Completion date May 2021

See also
  Status Clinical Trial Phase
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03706599 - Fever Infants and Therapeutic Education in Emergency Department N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT01782183 - Thermographic Characteristics of Sore Throat by Thermographic Camera N/A
Withdrawn NCT00800696 - Preventive Oral Care N/A
Completed NCT02689193 - IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Completed NCT02212990 - The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine N/A
Completed NCT01869699 - Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults Phase 4
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Completed NCT01194557 - Introducing Rapid Diagnostic Tests Into the Private Health Sector N/A
Completed NCT00969176 - Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates Phase 2/Phase 3
Completed NCT00940654 - The Fever and Antipyretic in Critically Illness Evaluation Study N/A
Recruiting NCT00729976 - Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study. Phase 4
Recruiting NCT00389272 - Adding a Second Drug for Febrile Children Treated With Acetaminophen N/A
Completed NCT00257790 - The Tobramycin Study Phase 4
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Completed NCT02595827 - Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo Phase 3
Recruiting NCT06061575 - Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients Phase 4
Recruiting NCT06038617 - Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children Phase 4