NCT02937129

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 10, 2016

Last Update Submit

October 15, 2016

Conditions

Fever

Keywords

Infrared tympanic thermometerAxillary thermometerMercury glass thermometerAdult emergency department

Outcome Measures

Primary Outcomes (1)

  • The body temperatures of fever patients measured by the infrared tympanic thermometer

    1. Fever patients were measured by the infrared tympanic thermometer in the emergency department. 2. Their tympanic temperatures were obtained from both sides of the body three times. 3. 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

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Febrile patients defined by a cut off of 37.5°C measured by axillary mercury thermometer were enrolled. Patients who meet the exclusion criteria were excluded.

You may qualify if:

  • Above 37.5°C measured by axillary mercury thermometer

You may not qualify if:

  • otitis external/media
  • soft-tissue infection over the axillary fossa and forehead
  • complete occlusion by earwax
  • severe illness
  • trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FeverEmergencies

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 18, 2016

Study Start

August 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 18, 2016

Record last verified: 2016-10