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

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

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.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 1125

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Human subject above the age of 18

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Quanzeng Wang
• Collaborators: University of Maryland, College Park

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): April 28, 2017
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: FDA RIHSC Protocol #16-011R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes