Ignite Creation Date:
2024-05-06 @ 1:27 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01817881
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2013-03-18
Brief Title:
Investigation of the Accuracy of Temporal Artery Thermometers
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 03 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 379 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 03 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None