Investigation of the Accuracy of Temporal Artery Thermometers

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817881
• Other study ID #: 2013-BBH-AKM/MMA-Exerg
• Status: Completed
• Phase: N/A
• First received: March 18, 2013
• Last updated: June 18, 2013
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• given informed consent

Exclusion Criteria:

• constipation

• anal disorders

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sepsis

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital: Bispebjerg - AKM-MMA	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between temperatures measured by temporal artery thermometers and rectal thermometers		6 months	No
Secondary	Reproducibility of temporal artery thermometers' measurements		6 months	No