Investigation of the Accuracy of Temporal Artery Thermometers

NCT ID: NCT01817881

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

385 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* given informed consent

Exclusion Criteria

* constipation
* anal disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christian Maschmann, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanne H Nygaard, RN

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital Bispebjerg

Locations

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Copenhagen University Hospital: Bispebjerg - AKM-MMA

Copenhagen, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Nygaard H, Maschmann C, Ekmann A. Comparison between temporal and rectal temperature measurement. Dan Med J. 2020 Oct 20;67(11):A04200270.

Reference Type DERIVED
PMID: 33215602 (View on PubMed)

Other Identifiers

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2013-BBH-AKM/MMA-Exerg

Identifier Type: -

Identifier Source: org_study_id

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