Investigation of the Accuracy of Temporal Artery Thermometers

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01817881
• Collaborator: (none)
• Enrollment: 385
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 127.4

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Mar 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Outcome Measures

Primary Outcome Measures

1. Difference between temperatures measured by temporal artery thermometers and rectal thermometers [6 months]

Secondary Outcome Measures

1. Reproducibility of temporal artery thermometers' measurements [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• given informed consent

Exclusion Criteria:

• constipation

• anal disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Copenhagen University Hospital: Bispebjerg - AKM-MMA	Copenhagen	Capital Region	Denmark	2400

Sponsors and Collaborators

• Bispebjerg Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian Maschmann, MD, MD, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT01817881
• Other Study ID Numbers: 2013-BBH-AKM/MMA-Exerg
• First Posted: Mar 26, 2013
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

Study Results

No Results Posted as of Jun 19, 2013