Clinical Trials Directory

Trials / Completed

CompletedNCT01817881

Investigation of the Accuracy of Temporal Artery Thermometers

Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement

Status
Completed
Phase
Study type
Observational
Enrollment
385 (actual)
Sponsor
Bispebjerg Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether temporal artery thermometers are accurate tools in temperature measurements of patients presenting to the Emergency Department. The investigators´ hypothesis is that there is a difference of \> 0,3 degrees centigrade (Bland-Altman) between the temperatures measured with the temporal artery thermometers used at the investigators´ hospital (Exergen TAT-5000) and those measured with rectal thermometers (OMRON MC-341-E), which is considered to be the gold standard in Denmark defined by the Danish Center for Clinical Guidelines. The investigators furthermore hypothesize that the difference between these measurements is greater if measured in a patient with hyperthermia (temperature \> 37,9 degrees Centigrade).

Detailed description

Accurate temperature measurement on patients presenting to the Emergency Department is of great importance since it has significant influence on the further treatment of the patient. At Bispebjerg Hospital temporal artery thermometers are being implemented as they provide a fast and comfortable temperature measurement compared to rectal thermometers, who are considered to be the gold standard, defined by the Danish Center for Clinical Guidelines. The scientific proof for their accuracy compared to rectal thermometers in adult patients is insufficient though. The purpose of this study is to determine the difference between temperatures measured by a temporal artery thermometer (Exergen TAT-5000) and a rectal thermometer (OMRON MC-341-E) in patients presenting to the Emergency Department at Copenhagen University Hospital: Bispebjerg. The investigators hypothesize that there will be an average difference of at least 0,3 degrees centigrade between those two types of measurements (Bland-Altman). Based on a significance of 5% and a power of 80% the number of patients was calculated to 385, including an estimated 10% dropout.

Conditions

Timeline

Start date
2013-03-01
Primary completion
2013-06-01
Completion
2013-06-01
First posted
2013-03-26
Last updated
2013-06-19

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01817881. Inclusion in this directory is not an endorsement.