We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Accuracy of Temporal Artery Thermometers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01817881
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Christian Maschmann, MD, Bispebjerg Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 > 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).

Condition or disease
Sepsis

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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Difference between temperatures measured by temporal artery thermometers and rectal thermometers [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Reproducibility of temporal artery thermometers' measurements [ Time Frame: 6 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency Department University Hospital
Criteria

Inclusion Criteria:

  • given informed consent

Exclusion Criteria:

  • constipation
  • anal disorders
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817881


Locations
Layout table for location information
Denmark
Copenhagen University Hospital: Bispebjerg - AKM-MMA
Copenhagen, Capital Region, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Layout table for investigator information
Principal Investigator: Hanne H Nygaard, RN Copenhagen University Hospital Bispebjerg
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Christian Maschmann, MD, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01817881    
Other Study ID Numbers: 2013-BBH-AKM/MMA-Exerg
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013