Investigation of the Accuracy of Temporal Artery Thermometers

• ClinicalTrials.gov Identifier: NCT01817881
• Recruitment Status: Completed
• First Posted: March 26, 2013
• Last Update Posted: June 19, 2013
• Sponsor: Bispebjerg Hospital
• Information provided by (Responsible Party): Christian Maschmann, MD, Bispebjerg Hospital

Tracking Information

• First Submitted Date: March 18, 2013
• First Posted Date: March 26, 2013
• Last Update Posted Date: June 19, 2013
• Study Start Date: March 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 21, 2013): Difference between temperatures measured by temporal artery thermometers and rectal thermometers [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 21, 2013): Reproducibility of temporal artery thermometers' measurements [ Time Frame: 6 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigation of the Accuracy of Temporal Artery Thermometers
• Official Title: Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement
• 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).
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Emergency Department University Hospital
• Condition: Sepsis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Nygaard H, Maschmann C, Ekmann A. Comparison between temporal and rectal temperature measurement. Dan Med J. 2020 Oct 20;67(11):A04200270.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2013): 385
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• given informed consent

Exclusion Criteria:

• constipation
• anal disorders

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01817881
• Other Study ID Numbers: 2013-BBH-AKM/MMA-Exerg
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Christian Maschmann, MD, Bispebjerg Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Bispebjerg Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Hanne H Nygaard, RN; Copenhagen University Hospital Bispebjerg

• PRS Account: Bispebjerg Hospital
• Verification Date: June 2013