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

NCT04370743 | Completed FDA Device

• 1 other identifier: FDA RIHSC Protocol #16-011R
• Study Type: observational
• Target: 1,125
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group 1

Other: No intervention

Interventions

No intervention OTHER

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Human subject above the age of 18

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quanzeng Wang: lead
• University of Maryland, College Park: collaborator

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Biomedical Engineer

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 1, 2020
• Study Start: November 30, 2016
• Primary Completion: April 28, 2017
• Study Completion: April 25, 2018
• Last Updated: May 1, 2020

Record last verified: 2020-04