NCT04397380

Brief Summary

This study will refine and pilot the feasibility of introducing a thermal imaging test to detect fever in 100 patients being triaged within the Emergency Department. The only additional research requirement for the patient is to have a thermal image of their face taken. Other triage tests will be routine. The aims of the feasibility study are to:

  • Understand the acceptability of introducing the intervention within the Emergency Department setting
  • Establish indicative patient recruitment numbers per week
  • Determine the likely proportion of patients recruited from this group who have a high temperature
  • Provide preliminary evidence that the technology can identify a high temperature in this diverse group of patients
  • Provide preliminary data for machine learning training to support classification of patients as being with or without fever The feasibility study will then inform the design and size of larger study to further develop and validate the the thermal imaging screening test to provide a 'with/ without' fever result.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

14 days

First QC Date

May 16, 2020

Last Update Submit

May 20, 2020

Conditions

Keywords

Thermography

Outcome Measures

Primary Outcomes (1)

  • Temperature

    Measurement of temperature

    During Emergency Department Stay (first 4 hours of hospitalisation)

Study Arms (1)

ED Patients

Patients Presenting in Emergency Department

Device: ThermographyDevice: Tympanic Temperature

Interventions

Measure Temperature using Thermal Camera

ED Patients

Measure Temperature using Tympanic Temperature

ED Patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending Queen Elizabeth University Hospital Emergency Department requiring triage

You may qualify if:

  • Patients ≥ 16 years old
  • 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)

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

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, G52 4TF, United Kingdom

Location

MeSH Terms

Conditions

Fever

Interventions

Thermography

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisThermometryInvestigative Techniques

Study Officials

  • David J Lowe, MBChB

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Lowe, MBChB

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr David J Lowe

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 21, 2020

Study Start

May 20, 2020

Primary Completion

June 3, 2020

Study Completion

July 1, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations