NCT02977481

Brief Summary

Ear thermometers are often requested to be used rather than rectal thermometer (gold standard) for measuring the body temperature, as this method is faster and more user friendly. Former ear thermometers did not meet the required standards of accuracy for clinical use. However, a new generation of ear thermometers have been developed and widely used in the Emergency departments in Denmark. The devices have only been evaluated in two studies on adult populations, with conflicting results. This cross-sectional study will examine patients by measuring both ear and rectal temperature in the same patient at the same time on admission to an emergency department, to evaluate if temperature measured in the ear can be used as the standard temperature measurement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

November 18, 2016

Last Update Submit

May 17, 2017

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

  • The Body Temperature in Celcius degrees

    Up to 24 hours after arrival to Emergency Department

Eligibility Criteria

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

600 adult patients admitted to emergency department

You may qualify if:

  • admission to emergency department

You may not qualify if:

  • no rectum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aabenraa Sygehus Emergency Department

Aabenraa, 6200, Denmark

Location

Related Publications (1)

  • Mogensen CB, Vilhelmsen MB, Jepsen J, Boye LK, Persson MH, Skyum F. Ear measurement of temperature is only useful for screening for fever in an adult emergency department. BMC Emerg Med. 2018 Dec 3;18(1):51. doi: 10.1186/s12873-018-0202-5.

    PMID: 30509206DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst professor

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 30, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)