Principles and Test Methods of Non-contact Body Thermometry

NCT05247736 | Unknown FDA Device

• 1 other identifier: ClinicalStudyAugust2021
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Long-wavelength infrared (IR) detectors have a more than 20-year history in medical thermometry and have been used widely for febrile screening. However, over the past year and a half, public health entities, medical professionals, and the general public have begun to question the claimed accuracy of non-contact body thermometry. The standard assessment of a device's performance relies on clinical testing with febrile individuals, yet this practice may have inadvertently allowed the approval of IR systems that are unable to detect moderate fevers. The ability to test device performance without relying on febrile test participants would have important ramifications for public health, especially if this test discovered undisclosed differences in accuracy in widely used devices. The aim is to examine the effect of the local environment and the physiology of the human body on the relationship between core body temperature and inner canthi (region near tear duct) skin temperature measured using non-contact thermal imaging and to use of this relationship to test actual device performance at detecting simulated elevated temperatures, without requiring volunteers having actual elevated temperatures. The overall goal of this research study is to validate and improve the science of non-contact core body temperature measurement.

Conditions

Thermometry

Keywords

non-contact infrared thermometry; thermal imaging; elevated body temperature; febrile

Outcome Measures

Primary Outcomes (3)

• Clinical Bias (CB)

  Average difference between device measurement and reference measurement as per ASTM E1965-98

  10 months

• Limits of Acceptability (LA)

  Two times standard deviation of device measurement as per ASTM E1965-98

  10 months

• Bland-Altman (BA) Plot

  Plot of device minus reference output versus reference output (or versus average of reference and device outputs)

  10 months

Interventions

Infrared Thermography DIAGNOSTIC_TEST

Non-contact body thermometry

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

Participants will be selected from those responding to electronic advertisement on St Olaf College internal email lists and message boards. It is expected that the majority of the study population will be students, with a small proportion of Staff and Faculty.

You may qualify if:

• Age \> 18.
• Have received a clinical oral thermometry measurement in the past.

You may not qualify if:

• Contraindication to oral temperature measurement.
• Inability to follow instructions.
• Any diagnosis associated with abnormal core thermoregulation, e.g. autonomic dysfunction.
• Obvious signs of tissue damage present in either inner canthus.
• Facial artery abnormality if previously diagnosed.
• Experienced discomfort while receiving most recent clinical oral thermometry measurement.

Sponsors & Collaborators

• Thermal Diagnostics LLC: lead

Study Sites (1)

St. Olaf College

Northfield, Minnesota, 55057, United States

Location

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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 21, 2022
• Study Start: July 22, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The first set of 28 subjects' data is available as of Jan 24, 2022

Locations

US (1)