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临床试验/NCT01817881
NCT01817881已完成不适用

Investigation of the Accuracy in the Use of Temporal Artery Thermometers for Non-invasive Temperature Measurement

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
385
试验地点
1
主要终点
Difference between temperatures measured by temporal artery thermometers and rectal thermometers

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • given informed consent

排除标准

  • constipation
  • anal disorders

结局指标

主要结局

Difference between temperatures measured by temporal artery thermometers and rectal thermometers

时间窗: 6 months

次要结局

  • Reproducibility of temporal artery thermometers' measurements(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Maschmann, MD

MD

Bispebjerg Hospital

研究点 (1)

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