NCT02274597

Brief Summary

The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 27, 2015

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

October 22, 2014

Last Update Submit

April 24, 2015

Conditions

Hypothermia

Keywords

hypothermiapre-hospitalepitympanictemperature

Outcome Measures

Primary Outcomes (1)

  • Temperature in degrees celsius

    The temperature will be recorded for a total of 10minutes during four different scenarios and compared to the rectal temperature

    The patients will be followed during the induced environmental factors, an expected average of 1 hour/participant.

Study Arms (1)

Environmental impact on epitympanic temperature measurment

volunteers exposed to different environmental factors to simulate field settings

Device: metraux epitympanic thermometer

Interventions

metraux epitympanic thermometerDEVICE

accuracy of epitympanic temperature measurement in different environmental settings

Environmental impact on epitympanic temperature measurment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Adult 18-60 years
  • no medication
  • healthy, no chronic illness
  • no acute illness on study day
  • No pathology in ear canal on otoscopy

You may not qualify if:

  • Pathology in ear canal
  • non-consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Skaiaa SC, Brattebo G, Assmus J, Thomassen O. The impact of environmental factors in pre-hospital thermistor-based tympanic temperature measurement: a pilot field study. Scand J Trauma Resusc Emerg Med. 2015 Sep 24;23:72. doi: 10.1186/s13049-015-0148-5.

    PMID: 26400226DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leiv Arne Rosseland, MD,Phd

    Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2014

First Posted

October 24, 2014

Study Start

March 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

April 27, 2015

Record last verified: 2014-10