Evaluation of Infrared Cameras and Non-contact Infrared Thermometers for Measuring Body Temperatures

Fever Clinical Trial

Official title:

Evaluation of Temperature Detecting (Infrared) Cameras and Non-contact (Infrared) Thermometers (NCITs) for Measuring Body Temperatures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370743
• Other study ID #: FDA RIHSC Protocol #16-011R
• Status: Completed
• Start date: November 30, 2016
• Est. completion date: April 25, 2018

Study information

• Verified date: April 2020
• Source: Food and Drug Administration (FDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fever is one of the key symptoms exhibited by contagious patients infected with the Ebola and other viruses. Thermographs and non-contact infrared thermometers (NCITs) are commonly used as early detection tools for screening and isolating sick individuals in healthcare settings and transit centers such as airports. The objective of this clinical study is to evaluate the temperature measurement accuracy of thermographs and NCITs. The study will be accomplished by establishing a protocol based on best practices for screening published in the IEC 80601-2-59:2008 Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening standard, performing initial measurements in patients to optimize clinical procedures, then performing quantitative clinical measurements in febrile and afebrile human subjects to compare thermographs - used in accordance with recognized best practices for measurement - with NCITs for fever screening. Since thermographs and NCITs represent the only currently viable mass screening approaches for infectious disease pandemics, like the recent Ebola virus disease (EVD) outbreak in West Africa, the study will evaluate these thermal modalities as medical countermeasures for fever-related pandemics and therefore improve response to these diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1125
• Est. completion date: April 25, 2018
• Est. primary completion date: April 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any human subject above the age of 18 that can sit for about 40 minutes with permitted breaks as needed and follow the study instructions can be included.

Exclusion Criteria:

• Human subjects should be free of recent (1 week prior) or current disease affecting the ICR and forehead skin. They should not use topical cosmetics, creams or medications on the face on the day of participation.

Related Conditions & MeSH terms

• Fever

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Quanzeng Wang	University of Maryland, College Park

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating accuracy of infrared cameras and thermometers for skin temperature measurement	The temperatures of each participant were measured with two infrared (IR) cameras and multiple IR thermometers at different locations on facial skin. The measured temperatures were compared with oral temperature to evaluate the accuracy of IR cameras and IR thermometers.	Through study completion, about 2 year