Thales Thermography Triage (3T) - Pilot Project
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedMarch 11, 2021
March 1, 2021
1 month
September 25, 2020
March 7, 2021
Conditions
Outcome Measures
Primary Outcomes (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
First 4 hours of hospitalisation.
Study Arms (2)
ED Patients
Patients presenting in Emergency Department
ED Staff
Staff working within the Emergency Department
Interventions
Measure Temperature using 62 Max + Infra-red thermometer
Eligibility Criteria
All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage. All staff members working within Queen Elizabeth University Hospital Emergency Department.
You may qualify if:
- 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
You may not qualify if:
- Patients who do not have capacity to consent
- Patients attending ED who are fast-tracked without triage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Clyde and Glasgowlead
- Thales Groupcollaborator
Study Sites (1)
Queen Elizabeth University Hospital
Glasgow, G52 4TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr David J Lowe
Study Record Dates
First Submitted
September 25, 2020
First Posted
March 11, 2021
Study Start
November 1, 2020
Primary Completion
December 15, 2020
Study Completion
May 1, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share