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Completed

NCT Number: NCT04370743

Evaluation of Infrared Cameras and Non-contact Infrared Thermometers 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Evaluating accuracy of infrared cameras and thermometers for skin temperature measurement

    Time frame: Through study completion, about 2 year

    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.

Sponsors and collaborators

Lead sponsor

Quanzeng Wang

Fed

Collaborators

  • University of Maryland, College Park

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 1, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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