跳至主要内容
临床试验/NCT00137228
NCT00137228已完成不适用

The Reliability and Concurrent Validity of the Figure-of-Eight Method of Measuring Hand Edema in Patients With Burn Injuries

United States Army Institute of Surgical Research2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.

研究概览

简要总结

The purpose of this study is to determine the reliability and concurrent validity of the figure-of-eight method of measuring hand edema in the burn patient population. Establishing the reliability and validity would enable a more time efficient assessment than the currently accepted methods.

详细描述

A prospective study involving 33 burn patients admitted to the US Army Burn Center. Two raters will perform three separate blinded measurements for hand edema using the figure-of-eight measurement technique. A third rater will then perform two blinded measurements using water volumetry. All measurements will be read and recorded by an independent recorder. The three measurements of rater 1 and 2 will be analyzed to determine intratester reliability. The average of the three figure-of-eight measurements will be compared to measure intertester reliability. The two volumetry measurements will be compared to determine intratester reliability. The average of the 2 volumetry measurements and the average fo the three figure-of-eight measurements will be used to determine concurrent validity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female 18-89 years old
  • Admitted to the United States (U.S.) Army Burn Intensive Care Unit (ICU) or ward with burn injury and the presence of bilateral or unilateral hand edema

排除标准

  • Subject unable to be placed in test position for volumetry testing or the presence of a medical condition, as defined by a physician, that precludes the safe use of volumetry.
  • Subject is unable to tolerate his/her hand(s) being immersed in room temperature water for volumetry testing.
  • Subject does not have any of the bony landmarks (due to amputation, previous surgery) required to perform the figure-of-eight measurement

结局指标

主要结局

The figure-of-eight method for measuring hand edema in burn patients is just as reliable and valid as water volumetry measurement.

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
United States Army Institute of Surgical Research
申办方类型
Fed

研究点 (2)

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