Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department

Fever Clinical Trial

Official title:

Clinical Accuracy and Reliability of Infrared Tympanic Thermometer in an Adult Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937129
• Other study ID #: 20151A010093
• Status: Completed
• Phase: N/A
• First received: October 10, 2016
• Last updated: October 15, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The primary aim of this study was to determine the accuracy of an infrared thermometer compared to the gold standard, mercury-in-glass thermometer. The secondary aim was to compare tympanic and axillary temperature measurements by evaluating agreement and correlation to determine whether an infrared tympanic thermometer can replace an axillary mercury thermometer in the emergency department.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Above 37.5°C measured by axillary mercury thermometer

Exclusion Criteria:

1. otitis external/media

2. soft-tissue infection over the axillary fossa and forehead

3. complete occlusion by earwax

4. severe illness

5. trauma

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Emergencies
• Fever

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The body temperatures of fever patients measured by the infrared tympanic thermometer	Fever patients were measured by the infrared tympanic thermometer in the emergency department.; Their tympanic temperatures were obtained from both sides of the body three times.; Use statistical methods to evaluate the relevance and consistency between the tympanic temperatures and gold standard temperatures(measured by the glass mercury thermometer).	up to 5 months	Yes